Biolis 30i

Automated Clinical Analyzer
Operator’s Manual
Ver.1.00
TOKYO BOEKI MEDISYS INC.

㻌
㻌
Original Instructions
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Contact Address for System Trouble
We appreciate your adoption of our Automated Clinical Analyzer.

This system is produced under the severe quality control and production
management.
But if the system has any trouble, please contact one of our offices without
hesitation.
In case of trouble, we would like to ask you to let us know the following
information, which may make us rapid action.
Serial No.
Installation date
System Software Version
Status of the trouble including estimated cause of the trouble
Also if you have any question regarding analyzer function, or if you want to
have technical training information, please contact one of our offices .
Manufactured by Tokyo Boeki Medisys Inc.

1-14-21, Higashitoyoda, Hino-shi, Tokyo 191-0052, Japan
Tel: (81)-42-587-7777

Caution
࣭This analyzer system may cause unpredictable accident or injury, it if is improperly installed or
improperly operated. Therefore, please follow the instruction of operation manual strictly.
࣭Please read the ࠙Safety cautionࠚ certainly, in advance. You should not do the following action,
without our approval beforehand.
࣭Modification for the analyzer
Addition of an attachment, supplied from the other maker than us.
࣭Self-repair or parts replacement
Self-adjustment of the points, assigned as qualified service engineer only.
࣭If you conflict the above, you may loose our assurance and maintenance agreement does not cover
the trouble.
࣭For the safety operation of the analyzer, it is necessary to do daily maintenance by yourself, but
also the inspection of the whole analyzer by a qualified service engineer, is necessary at the time of
consumable replacement or at the time of proper interval to keep smooth operation.
࣭For the accident or the trouble, without above inspection, we are not responsible.
࣭After analyzer installation has finished, if position movement, transfer, resale or abolition is
necessary, please let us know. If the above action has done without presence of qualified engineer,
we will not responsible for the accident or trouble after that.
࣭The maintenance function parts, which are necessary to keep analyzer function, will be stored for 7
years after the sales date. If you want to have these parts over 7 years, please consult to us within
storage period.
࣭The contents of this operation manual and software specification may change without notice.
࣭If you find any defects or mistakes in this manual, please let us know.
© Copyright 2011 Tokyo Boeki Medisys Inc.

Original Instructions
Registered trademark
࠙Windowsࠚis a registered trademark of Microsoft USA.
CSA Standard
This product meets the requirements of CSA.

“This product has been tested to the requirements of CAN/CSA-C22.2 No. 61010-1, second
edition, including Amendment 1, or a later version of the same standard incorporating the same
level of testing requirements”

Before the software installation, which is supplied from TOKYO BOEKI MEDISYS
INC (TMS), please read the following Software license agreement carefully.
Software installation to a computer is considered your agreement to the all items of
Software license agreement. If you find any objection, please let us know before
installation.
Software license agreement
The purpose of this Software license agreement is to establish mutual agreement

between customer and TMS on license of the software which belongs to TMS.
1 The right to use

The word Software license agreement means the privilege to use the supplied
software from TMS.
2 License
2.1 TMS permits to the customer a privilege to use the software, supplied by
TMS, under the condition of Software license agreement, antimonopoly and
non-transferring basis.
Note A privilege to use the consented software, means that the privilege
to install the supplied software on a computer, having recommended
operating system, and run the software on the computer.
2.2 All the privileges which are not included in Software license agreement
are reserved by TMS.
2.3 Any customer cannot do the following action such as: let a third party use
the consented software, disclose, takeout to the other countries by means of
setting the re-use rights and other methods.
3 Copyright
3.1 Copyright, trademark right, and intellectual property right related with
consented software and operation manual belong to TMS.
3.2 Any customer cannot do the following action, such as transfer, sublease,
disclosure, related to the consented software and operation manual, without
written permission of TMS in beforehand. No customer can set security
interest.
3.3 Any customer cannot do the following action, such as partial collection,
modification, reverse engineering, reverse compile, reverse assemble for the
consented software. If a customer did the above and any trouble occurred on
the analyzer, based on the modification, TMS has no responsibility.

4 Reproduction prohibition
Any customer cannot copy the consented software, even though partly.
5 Guarantee and responsibility limit

5.1 TMS does not guarantee, no defect on consented software, and also we do
not guarantee that our analyzer system fits customer’s special needs, or
useful for the needs.
5.2 TMS has no responsibility on the loss of customer or the third party, caused
by the usage of consented software or related action. Also we have no
responsibility on the claims of a customer caused by the third party.
6 Forbidden items
Customer should not do the following action intentionally.
6.1 Transmitting harmful computer program, such as virus, to TMS or the third
party.
6.2 The action violating the law and regulation.
6.3 The action inducing or promoting criminal acts and leading to criminal acts.
6.4 The action infringing copyright, trademark right, portrait right and other
right and profit of the third party.
6.5 The action of slander TMS or the third party and the action staining honor.
6.6 The action of publish or transmitting false information or information

leading to misunderstanding.
6.7 The action contrary to other public order and morals.
6.8 Other than the above items, any action which disturbs operation of TMS.
7 Effective period
7.1 This contract is active from the date of agreement, and active till failure of
the contract, by the procedure explained at the next article.
7.2 In spite of the above, the third article is active after the failure of the
contract.
8 Cancellation of the agreement

8.1 If the customer violates this agreement, TMS can notice the cancellation of

this agreement without any notification. Other than that, TMS can
demand on the loss, caused by the violation.
8.2 The customer can cancel this agreement by the abandonment of the
consented software.
9 The action after the agreement has over

When this agreement is cancelled based on the article 8, customer should abandon
the consented software and notify to TMS.
10 Conference
10.1 Regarding the subjects which are not covered by the agreement, customer
and TMS will discuss and reach to the conclusion by the basis of principle
of good health.
10.2 If you have any question regarding the agreement, please contact to TMS
by a document.

Operator’s Manual V1.00
Contents
Preface
Alarm code, guarantee, safety and caution for operation.
Chapter1 [Specifications and structure of the System]

To understand general view, analyzer construction is explained.
Chapter2 [Functions and principles]

Various functions, operating principle and operation method are explained.
Chapter3 [Explanation of each screen and operating condition]

Start-up operation and routine operation are explained.
Chapter4 [Explanation of each screen and operating condition]

Explanation on various test parameter input method.
Chapter5 [Maintenance]
Explanation on inspection method to keep the analyzer under the good condition.
Chapter6 [Check flag and alarm function]

Explanation on the alarm messages and on the action to take as the preparation
of alarm massage appears.
Consumables List

Operator’s Manual Preface
Preface
Introduction ---------------------------------------------------------------------- 0-2

1. Expression of Warning and Notice ------------------------------------ 0-3
2. Safety Caution ࣭Caution in Operation ------------------------------ 0-7
3. Warranty ---------------------------------------------------------------------- 0-10
4. Storage and Transportation Requirements ----------------------------- 0-12
5. Usage environment ---------------------------------------------------------- 0-12
6. Installation and Servicing ------------------------------------------------- 0-13
7. Cleaning and disinfection procedure ------------------------------------- 0-13
8. Position of the nameplate ------------------------------------------------- 0-13
0-1

V1.00
Introduction
This Automated Clinical Analyzer is an IVD medical equipment for indoor use and is
based on the colorimetric and turbidimetric measurement.
Its main application is expected to be colorimetric measurement, clinical chemistry
testing, immuno-serological testing, hematological testing and urine testing in
hospitals, clinical laboratories and other research laboratories.
This operation manual is composed of the following contents.
0-2

1. Expression of Warning and Notice
In this manual, the items you have to be careful for safety are indicated by the following
levels.
Classification of display
Caution 㸸If ignored, the accident may cause personal injury or heavy damage on the
instrument.
Warning 㸸If ignored, the accident may lead to death or heavy injury.
Note 㸸Pay attention, additional explanation.
Description of the mark
㸸Biohazard.
There is the risk of your being infected.
In case of treating samples that may be hazardous or infectious, wear rubber
gloves not to touch directly.
Any spills on the skin should be washed off with a great volume of water and
sterilized.
And consult a physician if necessary.
Also any spills on the system should be wiped off and sterilized at once.
㸸This mark means electric shock if touched.
㸸This mark means laser light leakage. Do not see by naked eye.
㸸This mark means high temperature. Keep out from burn.
㸸This mark means do not touch with wet hand.
㸸This mark means electric ground is necessary.
㸸This mark means to protect eye, wear protective goggle.
㸸This mark means do not touch with naked hand.
0-3

V1.00
Explanation of caution and warning seal
The following seal are stuck on the analyzer body as warning.

If this mark is attached to the analyzer, read the corresponding caution of the
operation manual. Never remove these seals for safety protection.
1) Warning label of top cover
Revolution, vertical movement hazard

Some units rotate and move up and down.
Location: top cover
2) Right side cover㸹ISE unit, Water supply/drain panel

Biohazard
If you operate the dangerous parts, please
wear glove.
3) Upper panel warning label
A
C
G
F
E
0-4

A: Lamp house
High temperature hazard

Scald by high temperature
If you operate the parts, turn off the main
breaker of the machine and disconnect the
cable.
Location : Lamp house (Lamp)
B: CWS

C: STM

Location: STM, STM for ISE
D: RTM1, RTM2

Location: RTM1, RTM2
E: Body
Biohazard
If you operate the dangerous parts, please
wear glove.
Location : Sample tray, Reagent tray
0-5

V1.00
F: Reagent tray
Injury hazard
Never open this cover while
analyzer is in operation.
Only Access cover when green
tray replace light is on.
G: Sample tray
Injury hazard
Never open this cover while
analyzer is in operation.
Only Access cover when green
tray replace light is on.
0-6

2. Safety Caution ࣭Caution in Operation
Warning
1) Electric shock prevention
When electrically charged, never open rear cover nor covers of both
sides. It may cause electrical shock.
2) Usage
Mainly used for clinical chemistry electrolyte tests and
immuno-serological test of water soluble
samples.
The system may not be proper to use for the purpose other than the
above.
Caution
1) Moving parts while operation

(1) Do not touch sample pipette, reagent pipette nor washing
mechanism in operating.
(2) During the measurement, the analyzer will stop immediately if the
unit is not correct position under own check program.
(3) Two tray replace lamps are on the analyzer. When the tray replace
lamp is off, do not touch the sample and reagent tray. You might be
injured.
2) Light from light source㸭Bar code reader LED class 1

Do not look at light source by naked eyes.
It might hurt your eyes.
Wearing safety goggles for ultra violet is recommended.
3) Sample handling
(1) Do not touch infectious or dangerous samples directly.
If the system is contaminated, please wipe out at once.
(2) Please make sure that no insoluble matter, such as fibrin, is in
sample. It may give improper results.
4) Waste liquid treatment

(1) Waste liquid should be treated properly under the related regulation.
It may cause pollution problem.
(2) About the concentration of poisonous chemicals in a reagent, please
ask the reagent maker.
0-7

V1.00
5) Accuracy of measured data

During the operation, please check the system condition by
measuring control samples.
Inaccurate test results may lead wrong diagnosis and improper
patient treatment.
6) Inflammable substance
Do not use inflammable substance around the system. It might cause
fire or explosion.
7) Warning mark
When warning or caution mark peeled off, contact our serviceman to
replace by a new one.
8) Specified manner
If the system is used in a manner not specified by the manufacturer,
the protection provided by the system may be impaired
9) Power plug
(1) Do not plug or unplug with the wet hands. It might cause electric
shock.
(2) Do not pull the cord when unplugging. It might cause electric shock.
10) Protective grounding

Use a 3-pin-plug whose ground terminal will be connected first and
be sure that the earth resistance of terminal is less than 100 ohm. It
avoids electric shock.
11) Installed and used in environmental conditions

Please observe the conditions listed in the Operation manual.
12) Moving or Rejection

When not using the system for a long period, or when moving or
rejecting the system, remove biohazards.
13) Limited operator

(1) The operation of system should be controlled by a person who had
training of an organization authorized by the distributor.
(2) If used for clinical testing, the operation should be controlled by a
medical doctor or a medical technologist.
14) Operation and maintenance

(1) During the operation and maintenance, please follow the instruction
and never touch the points besides designated.
0-8

15) Treatment on reagents and others

(1) Reaction cuvette, sample cup and waste liquid line are not
sufficiently tolerant to organic solvents. Do not use solvents.
(2) Do not use sticky substance on sample probe, reagent probe nor
reaction cuvette.
(3) Handling the reagents, which is supplied by reagent makers, please
keep the caution from the reagent maker.
16) Top cover

(1) Take care not to have your fingers pinched, when opening or closing
the top cover. You might be hurt.
(2) Do not put anything on the top cover. Liquid spilt into the air hole
might cause a malfunction.
17) Piping
In installation of the system and in feeding liquid or drainage, take
care not to bend or break piping.
18) Washing solution

Do not use other washing solution than the certified one for the
system. It might cause a malfunction.
19) Static electricity

Do not put a thing charged with static electricity on the system, nor
touch with hands charged with static electricity. It could cause a
malfunction of the system.
20) Emergency
For emergency stop, turn off main breaker at the left side panel.
21) WEEE directives

(1) Do not throw away this instrument with wastes. This instrument
has to be thrown away as medical waste. Strictly follow laws and
regulations of your country when discarding the instrument.
(2) When discarding the instrument, please contact Tokyo Boeki
Medisys Ltd. or our distributor in your country.
(3) Please cooperate with recycling to follow a global environment.
(4) The trash box mark in the right means the WEEE directives.
0-9

V1.00
3. Warranty
1) Warranty period
Twelve months after the installation date or fourteen months from shipment date
from Japan, whichever comes earlier.
2) Warranty and remedy

- We warrant that, during the warranty period, the analyzer operates in accordance
with our standard technical specifications (failure to operate is called as “Defect”).
- When a Defect is found and your written claim fully describing the details of the
same is accepted by the end of the warranty period, we will, at our expense and sole
option, provide either of the following remedies:
(a) to supply and ship replacement parts on a FCA basis that are deemed necessary for
repair of the analyzer; or
(b) to repair and ship back the analyzer on a FCA basis, when the analyzer is brought to
the designated place at your expense.
-The above warranty and remedy are exclusive and in lieu of any other warranties
and remedies, whether in contract, tort or otherwise.
We will in no event held liable for consequential, incidental or special damages such
as loss of revenue, data and information, even if we have been notified or aware of
the possibility of such damages.
3) Warranty and remedy

- We will not be responsible for any defect or nonconformance, including all losses,
costs and damages incidental to them, when any one or more of the following applies.
In this section, the word “analyzer” includes its consumables and spare parts.
1. Unauthorized removal, displacement or transportation of the analyzer

after installation of the same;
2. Use of the analyzer under improper installation;
3. Unauthorized disassembly, modification or repair of than analyzer;
4. A damage or nonconformance caused by a natural disaster such as fires,
earthquakes and lightning;
5. When the computer used with the analyzer is installed with any unauthorized
program or is connected to any unauthorized network (including the
Internet);
6. Inappropriate storage or maintenance of the analyzer;
7. Incorrect operation of the analyzer;
8. Use of the analyzer under improper operating conditions
(including use under the atmosphere containing corrosive gas)
9. Use of unauthorized consumables or spare parts for the analyzer;
10. Normal wear and tear of the analyzer;
11. Incompatibility of the analyzer with other products (including that with
0-10

reagents);
12. A defect or nonconformance that you found or could have found at the time
of receipt of the analyzer such as loss of or apparent damage to the analyzer
and that you failed to promptly notify to us in writing;
13. Minor defect or nonconformance that does not affect operation, function
and performance of the analyzer; and
Any other defect or nonconformance that is not attributable to us.
̺The warrantees of consumables and spare parts of the analyzer are to be

accordance with its manufacturer's warranty.
̺In case any defect or nonconformance is found in the analyzer, both you and we
will, at its own costs respectively, cooperate to promptly determine the cause of
the same, whereby you will, upon our request, provide us with information in
writing that is necessary to verify such cause.
̺If we perform any remedy for a defect or nonconformance of the analyzer,

such as repair and replacement of the analyzer and payment of compensation
money (including offer of price discount), and subsequently it is found tha t any
one of the events contained in the foregoing (3) applies and that we are not
responsible for such defect or nonconformance, then you will, within fourteen
days after receipt of our invoice, reimburse us with all the costs we have incurred
associated with the remedy (including costs associated with the investigation
and dispatch of our personnel) and refund the full amount of the compensation
money we have paid to you. Delay in reimbursement or refund is subject to the
five percent monthly compound overdue interest or the maximum interest
permitted by applicable laws from the due date till paid in full.
0-11

V1.00
4. Storage and Transportation Requirements
1) Indoor.
2) No direct sunlight.
3) No dust.
4) Ambient temperature should be 1 ~ 45 Celsius degrees.
5) Ambient humidity should be 10 ~ 85% (no condensation).
6) No dropping.
7) No throwing down.
8) No upper load.
9) Transport condition is marked on the box. Follow the written instruction on a label.
10) Transportation and the movement of the equipment should be done by a trained
service engineer.
5. Usage environment
1) No dust, good ventilation.

2) No direct sun light.
3) The gradient of the table should be less than 5mm/m.
4) The table should be able to support over 100kgf/m2
5) Room temperature range is 15㹼30Υ, and deviation during test is ±2Υ.
6) Room humidity should be 45 ~ 80 %, and no condensation.
7) Small vibration
8) Voltage㸸AC100V㸭115V㸭220V㸭230V (± 10㸣)
9) Install away from high frequency electromagnetic wave emitting equipment (such as
centrifuge, electric discharge), preferably not in the same room.
10) Earth resistance of ground terminal should be less than 100 ohm.
11) Power supply capacity should be over 600VA.
12) No Multi-outlet extension code.
13) Please do not use the power supply cord except the following rating ;
Rating In AC 100V/115V ... 125V 7A or more
In AC 220V/230V ... 250V 3.5A or more
14) Outlet that insert to securely back.
15) The system should be installed at altitude less than 2000 meters.
16) Keep the space around the system for taking out the power cord in an emergency, for
good ventilation and for maintenance, as the following. Also keep the space of at least
100 cm over the system. (At the minimum)
0-12

6. Installation and Servicing
1) Installation
Installation and checking of deliveries or transport condition will be performed by our
serviceman.
Prepare a receptacle with earth terminal (3 terminals) and be sure the earth resistance
of terminal is less than 100 ohm.
When moving the system, consult our serviceman.
2) Servicing
Come in contact with us about servicing.
7. Cleaning and disinfection procedure
When you do the maintenance operation, wear protective globes, mask and glasses to
avoid the infection.
Wipe out the panels by dry cloth or soaked in diluted neutral detergent.
Do not use organic solvent such as Thinner or Benzene which will affect the paint and
shape.
¾ Disinfection
Wipe out the biohazard area (sample probe) by 70% ethanol. Clean up by de-ionized
water after disinfection. If you use ethanol for sterilization, be careful not to burn.
Keep away fire source.
8. Position of the nameplate
The position of the table is as follows.
0-13

Operator’s Manual Chapter 1
Chapter 1
Specifications and structure of the System
1.1 General Specifications ----------------------------------------------------------- 2

1.2 Structure of the System --------------------------------------------------------- 5
1.2.1 Over All Structure ------------------------------------------------------------ 5
1.2.2 Plan of the System Section ------------------------------------------------- 6
1.2.3 Rear view ----------------------------------------------------------------------- 6
1.2.4 Left Side Elevation of the System---------------------------------------- 7
1.2.5 Right Side Elevation of the System-------------------------------------- 8
1.2.6 Reservoirs----------------------------------------------------------------------- 9
1. Water Supply Reservoir (10L) ------------------------------------------------ 9
2. Drainage reservoir (10L) ------------------------------------------------------- 9
3. Alkaline and Acidic Cleaning Sol. Reservoir (3L) ----------------------- 10
4. Separate Collection Reservoir (5L)------------------------------------------ 10
1.2.7 Personal computer ----------------------------------------------------------- 11
1-1

V1.00
1.1. General Specifications
Item Contents
Discrete, Single line random access, multi-tests
Method
analysis
Test items on board 36 items 㸦24 items Option)+ ISE 3 items
270 tests/hr.
Throughput ࣭MAX 450tests/hr. (in case of loading ISE)
࣭90 test/hr. (HbA1c Item Only)
End point method, Rate method
Analysis method
ISE
Linear, Factor, Non-linear (Logit-log, Spline,
Calibration curve
Exponential, Polynomial)
About 10 min.
Reaction time
(1st react. about 5 min+ 2nd react. about 5 min.)
Tray mode Software tray
Patient sample tray : Tray No. 1 - 50
Tray kind Calibration tray : C1 – C6
QC sample tray : Q1 – Q3
Serum, Plasma, Blood cell ,Urine, Dialysate, CSF
Contents of test
(ISE not available for CFS and Blood cell)
Container Sample cup, Primary tube (5mL, 7mL, 10mL)
Patient sample : 1 -30 (Outside)

Standard sample, Blank sample : 1 - 45
ISE standard (for serum sample) : 2
ISE standard (for urine sample) :2
Sample
ISE standard (for dialysis ) :1
Sampler
QC sample :
¾ Patient sample tray, Calibration tray ( Inside) ; 31 - 45
¾ QC sample tray; 1 - 45
Washing : 3
ISE washing :1
Dispensation
2.0 – 25ȣL (0.1ȣL steps)
volume
0.5,6,10,20,30,40,50,60,70,80,90,100 times
(When dilution ratio is set 0.5, the sample volume is used
Dilution ratio
two times. Set the sample volume less than 12.5uL and
the total reaction volume less than 400uL.)
1-2

Item Contents
Dispensation R1 ;140-300 ȣL (1μL steps)
volume R2 ;20 -260 ȣL (1μL steps)
Number of
R1,R2 ;36position (Option R1,R2㸹24 position)
bottles on board
Reagent Reagents are cooled at 5 – 15 Celsius degrees.
Storage The reagent cooling becomes room temperature minus
13Υ when the room temperature is over 25Υ
36 item ; Single R1;40mL,Double R1; 25mL, R2;13mL
Bottle volume
(24item;Single R1 60mL, Double R1;40mL,R2;20mL)
Mixing method 2 rooms air pressure mixing (without a stirrer)
Temperature
Direct block heating
control
Reaction
37 plus-minus 0.1Celsius degrees
temperature
Reaction
Material㸸Plastics
tray
Optical path length : 8 mm
Reaction cuvette
Number of cuvette : 60 pieces (semi-disposable)
Reaction volume : 140 – 400 micro-liter
Optical
Cuvette direct measurement
absorption
Fixed 13wavelengths
Wavelengths ¾ 340,380,405,450,480,505,546,570,600,660,700,750,
800nm
Spectro-ph
otometer Light detector Silicon photo-diode
Wavelength
Plus-minus 1.5nm
accuracy
Linearity range 0 - 2.5 Abs.
Light source Halogen lamp
Calculation Calculation based on user ’s formula
between item Correlation factor
Reaction curve monitor
Monitor function Data review
User
Run-monitor
interface
Westgard algorithms
Quality control
Within day, day to day
Data storage
Based on the PC specification
capacity
InstrumentЍPC㸸LAN(TCP/IP)
System interface
PCЍLIS㸸LAN㸦TCP/IP㸧(HL7 Ver2.5standard)
1-3

V1.00
Item Contents
Equipment Class Class Ϩ
Over voltage Category Category ϩ
Pollution Degree Pollution Degree 2
Power supply AC100V/115V/ 220V/230 V plus-minus 10 %
Frequency 50/60 Hz
Electric consumption 600 VA
Grounding Resistive less than 100 ohm
15 – 30 Celsius degrees
Ambient temperature
(During operation Plus-minus 2 Celsius degrees/hour)
Ambient humidity 45 – 80% (No condensation)
Water consumption About 3.8L/hour
Dimension (system) 800 (W) 670 (D) 555 (H) mm
Weight Approx. 95kg
Electrodes Na, K, Cl and Reference electrode.

60 micro-liter for Serum ,Plasma and Dialysis
Sample volume :
120 micro-liter for diluted urine (Use sextuple diluted
Measurement
sample by urine diluent)
45 seconds for serum and dialysis
Analysis time
ISE 37 seconds for diluted Urine sample
Serum㸹Calibrator ( A ,B )
Reagents Urine㸹Calibrator 1 for urine, Calibrator 2 for urine
Dialysis; Dialysis calibrator D
Sample volume : 120 micro-liter for Serum, Plasma and Dialysis
Calibration 240 micro-liter for diluted urine
1-4

1.2. Structure of the System

The instrument is consisted with sampler (sample tray), sampling mechanism,
reagent tray, reagent transfer mechanism, reaction tray (with reaction cell), mixing
unit, reaction cell washing station and spectrophotometer.

1.2.1. Over All Structure
'
$
% A㸸Instrument
B㸸Personal computer
&
C㸸ISE drainage reservoir
D㸸Tanks
㸺Top view㸼
$
% A㸸Instrument
& B㸸Personal computer
C㸸ISE drainage reservoir
'
D㸸Tanks
E㸸Separate collection reservoir
F㸸Drainage reservoir
G㸸Water reservoir
H
H,I㸸Cleaning solution reservoir
(
()*+, ࣭Alkaline detergent
࣭Acidic detergent
㸺System front view㸼
*BothAcidic andAlkaline Cleaning Solution Reservoirs must be set the same level of the instrument or below
the instrument.
*Separate Collection Reservoir, Drainage Reservoir and Water Reservoir must be set below the instrument
level
1-5

V1.00
1.2.2. Plan of the System Section
A㸸Sample tray
) B㸸Sample probe
+ *
C㸸Reagent tray
D㸸Reagent probe
E㸸Reaction tray
F㸸Mixing
( %
G㸸Cuvette washing station
H㸸Lamp house
& $
'
The plan when the top cover is removed
1.2.3. Rear view
I㸸Nameplate
- . J,K,L㸸Fan
/
,

Rear view

1-6

1.2.4. Left Side Elevation of the System

$

Left Side

A:Main power switch panel
B:LAN
Connect to the PC
C: Main power switch
I ON
The reagent cooler is working
○ OFF
All the functions stop
D:Main Fuse
Time lag fuse (AC250V 6.3A)
C: AC power supply
A. Main power switch
l

1-7

V1.00
1.2.5. Right Side Elevation of the System
A:ISE module (Inside the door)

B:Water supply/drain panel
%
$
Right Side
& '()*
B: Water supply/drain panel
Upper : Cable line (SW-1 㹼 5 )
Connect each sensor cables
Lower : Piping line
Connect each tubes
C㸸Drainage reservoir
Water supply/drain panel SW-1, WASTE-1
D㸸Separate collection reservoir (option)
SW-2, WASTE-2
E㸸Water reservoir
SW-3, WATER
F㸸Alkaline cleaning solution reservoir
SW-4, ALKALIN
G㸸Acidic cleaning solution reservoir
SW-5, ASID
1-8

1.2.6. Reservoirs
¾ Separate Collection Reservoir, Drainage Reservoir and Water Reservoir must be set
below the instrument level.
¾ Both Acidic and Alkaline Cleaning Solution Reservoirs must be set the same level
of the instrument or below the instrument.
1. Water Supply Reservoir (10L)

A㸸Tube㸦blue㸧
B㸸Cable
C㸸Float switch
D㸸Filter
E㸸To water supply/drain panel,
"WATER"
F㸸To water supply/ drain panel,
"SW-3"
Water Supply Reservoir

1) Please use ion-exchange water. (Electric conductivity < 1 micro S/cm)
2) Pure water line filter has to be replaced periodically.
3) If residual amount is less than a certain amount, an alarm is given.
2. Drainage reservoir (10L)

A㸸Cable
B㸸Float switch
C㸸To water suppl/drain panel,
“WASTE-1”(2 ports)
D㸸To water supply]/drain panel,
“SW-1”

Drainage reservoir
1) If the content exceeds a certain level, an alarm is given.

1-9

V1.00
3. Alkaline and Acidic Cleaning Sol. Reservoir (3L)

'
(
$ & A㸸Cable
B㸸Float switch
C㸸Tube (thin)
D㸸To water supply/drain panel
“ALKALIN” or “ACID”
% E㸸To water supply/drain panel
“ALKALIN-“SW̺4”
“ACID “SW - 5”
Alkaline Cleaning Sol. Reservoir
Cleaning Sol. Reservoir
Acidic

1) Please use exclusive dilute alkaline cleaning solution ( or acid cleaning
solution. )
2) Filter has to be replaced periodically.

4. Separate Collection Reservoir (5L)

A㸸Cable
B㸸Float switch
C㸸To water supply/drain panel,
“WASTE-2”
D㸸To water supply/drain panel,
“SW-2”
Separate Collection Reservoir

1-10

1.2.7. Personal computer

By the personal computer to be used, it depends on the placement of each terminal.
The personal computer instruction manual well we read, should be connected with
the device.
In addition, the handling on the PC alone, please refer to the PC instruction manual
for operations.
To find out actual ports to be used, please refer to the operation manual of your PC.
* Please use the PC that complies with IEC60950.

࣭PC specification (Recommendation)
Model All in one PC
OS Windows 10 64bit
CPU Intel Core i5/i7
Memory 8GB
Chip set Not specified
Storage 500GB Hard disk
Video chip Not specified
Video ram Not specified
Display resolution WXGAtt (1600x900) above
Display
Multi touch compatible
Speaker Yes
LAN Wired

࣭LAN cable specification (Recommendation)
Standard CAT5e (Category 5e) above

1-11


Chapter 2 Functions and principles

2.1 System overview ............................................................................................................... 3
2.1.1 System structure ....................................................................................................... 3
2.2 Principle of measurement ................................................................................................ 4
2.2.1 Analysis flow chart .................................................................................................... 4
2.2.2 Analysis process and optical measurement point ...................................................... 5
2.2.3 Peiciple of measurement and flow ............................................................................. 6
2.2.4 ISE (Option) Principle of measurement and flow ...................................................... 7
2.3 Units and functions .......................................................................................................... 8
2.3.1 Plane of main units ................................................................................................... 8
2.3.2 Sample tray ............................................................................................................... 8
2.3.3 Sample tranfe mechanism ......................................................................................... 8
2.3.4 Reagent tray .............................................................................................................. 8
2.3.5 Reagent transfer mechanism..................................................................................... 9
2.3.6 Reaction tray andreaction cell ................................................................................. 9
2.3.7 Mixing unit ................................................................................................................ 9
2.3.8 Cell washing station ................................................................................................ 10
2.3.9 Specto-photometer and measurement method ........................................................ 11
2.3.10 ISE Module (Option)................................................................................................ 12
2.3.11 HbA1c sample preparation ...................................................................................... 13
2.3.12 Sample clot detection............................................................................................... 14
2.3.13 Probe crash detection .............................................................................................. 15
2.4 Analysis type .................................................................................................................. 16
2.4.1 Kinds of analysis types ............................................................................................ 16
2.4.2 One point end assay .............................................................................................. 17
2.4.3 Two points end assay 1 ............................................................................................ 18
2.4.4 Two points end assay 2 ............................................................................................ 19
2.4.5 One point rate assay ................................................................................................ 20
2.4.6 Two points rate assay 1 ........................................................................................... 21
2.4.7 Two points rate assay 2 ........................................................................................... 22
2.5 Kinds of Calibrations...................................................................................................... 23
2.5.1 Linear 1 (Two points linear) .................................................................................... 24
2.5.2 Linear 2 (Multi-points linear) .................................................................................. 25
2.5.3 Factor ...................................................................................................................... 27
2.5.4 Non-linear ............................................................................................................... 28
1) Logit 1 ..................................................................................................................... 28
2) Logit 2...................................................................................................................... 29
3) Spline....................................................................................................................... 30
4) Exponential ............................................................................................................. 31
5) Polynomial ............................................................................................................... 32
2.6 ISE Module (Option)....................................................................................................... 33
2-1

V1.00
2.6.1 ISE calibration .........................................................................................................33

2.6.2 ISE concentration calculation ..................................................................................33
2.7 Linearity check ..............................................................................................................34
2.8 Prozone check ................................................................................................................35
2.9 Serum information (L-H-I) ............................................................................................36
2.10 Carryocer avoidance........................................................................................................37
2.10.1 Kinds of caryyover avoidances .................................................................................37
2.11 Automatic start-up, shut down and automatic maintenance ..........................................38
2.11.1 Automatic start-up and shut down ..........................................................................38
2.11.2 Automatic maintenance ...........................................................................................38

2-2


2.1 System overview

2.1.1 System structure

Sample pump
Mixing pump
Mixing

Cell washing
pump
Reagent pump
A/D converter

Drainage pump
Probe washing
pump

INTERFACE

Printer

TUBE LINE

CABLE LINE

㸺PC㸼

2-3

V1.00
2.2 Principle of measurement

2.2.1 Analysis flow chart
START
REACTION CELL CLEANING
WATER BLANK 2.4 min
EVACUATION
R1 DISPENSATION
0.4 min
SAMPLE DISPENSATION
MIXING 2 STAGES
5 .1min
1ST Reaction
R2 DISPENSATION 10.6 min
MIXING 2 STAGES
5.1min
2ND Reaction
END OF MEASUREMENT
CUVETTE CLEANING 2.4min
AUTO-STOP
2-4


2.2.2 Analysis process and optical measurement point
1㸧Analysis process

Measuring point19,37㸻8secࠊ54㸻24secࠊOther=13sec
㸺Explanation㸼
S : Sample dispensation
R1 : R1 dispensation
R2 : R2 dispensation
M : Mixing
2㸧Optical Measurement Point
Cycle after start Function Optical measurement
6, 7, 8 Water blank measurement 1, 2 ,3

11 R1 dispensation 6
13 Sample dispensation 8
13, 14 Mixing (R1 + sample) 8,9
36 R2 dispensation 31
37, 38 Mixing (R2 + reaction solution) 32, 33
60 Reaction drainage aspiration 55
* For 1st regent only system, there is not R2 dispensation.
2-5

V1.00
2.2.3 Principle of measurement and flow
1) Measurement principle
¾ The optical absorption is measured every one cycle.
¾ When the reaction tray rotates and the reaction cell passes
the optical measurement position, light absorption data are
measured.
2) Measurement flow
(1) When the start button is clicked, the cuvette washing unit starts
cleaning from the start cuvette.
࣭ Water blank is measured during cuvette cleaning.
࣭ These data are the basis of optical absorption (Absorption = 0)
to the following optical absorption measurement.
(2) The reagent tray rotates and transports the reagent bottle to the
reagent aspiration position.
(3) The R1 probe moves to the aspiration position, above the reagent
bottle, then moves down to aspirate the reagent.
(4) The R1 probe goes up and moves to R1 dispensation position and
waits for the cuvette coming to the dispensation position.
(5) The reaction tray rotates and moves to R1 dispensation position.
(6) R1 probe goes down into the reaction cell and dispenses the
reagent.
(7) The R1 probe goes up and moves to the probe washing pot and both
inside and outside are washed by de-ionized water there.
(8) The sample tray rotates and moves to sampling position.
(9) The sample probe goes to sample position and move down to
aspirate the sample.
(10) The sample probe moves above reaction cells.
(11) The reaction tray rotates and the R1 dispensed cell moves to sample
dispensation position.
(12) Sample probe goes down into the reaction cell and dispenses the
sample.
(13) The sample probe moves to the probe washing pot and both inside
and outside are washed with de-ionized water.
(14) The reaction tray rotates and the reaction cell of R1 and sample
moves to mixing position.
(15) The R1 and sample are mixed by air pressure of mixing unit.
࣭This mixing is repeated in the next cycle, two times in total.
(16) After 5 minutes of sample dispensation, the reaction tray rotates and
the reaction cell of R1 and sample moves to R2 dispensation position.
2-6


(17) R2 is dispensed by R2 probe, which has the same function as R1

probe.
(18) The R2 probe goes up and moves to the probe washing pot and both
inside and outside are washed by de-ionized water there.
(19) The reaction tray rotates and the reaction cell (R1, sample, R2)
moves to mixing position.
(20) The R1, sample and R2 are mixed by air pressure of mixing unit.
࣭ This mixing is repeated in the next cycle, two times in total.
࣭ No mixing from (16) – (20) is done when using mono-reagent.
(21) After 10 minutes of sample dispensation, the reaction liquid in the
reaction cell is aspirated out and ends the measurement.
࣭The measurement result is displayed in result screen.
(22) The used reaction cell is washed by reaction cell washing unit and
stop the movement automatically.
࣭When continue the measurement, start the analysis from (1)
2.2.4 ISE (Option) Principal of measurement and flow
1) Principle of measurement
¾ Ion selective electrode method (Direct method)
2) Measurement flow
¾ When measuring the calibration, perform the calibrator aspiration and
dispensation twice. The electro-motive force (mV) of second time result is
adopted.
¾ When measurement the urine, use urine diluted with the urine diluent
by six times.
(1) Cal-1 in the electrode unit is discharged.
(2) The sample tray rotates and moves to sampling position (sample cup or
primary tube).
(3) The sample probe goes to sample position and move down to
aspirate the sample.
(4) Sample probe goes up and move to sample pot position.
(5) Sample probe dispenses the sample into the sample pot.
(6) The sample probe moves to the probe washing pot and both inside
and outside are washed with washing solution.
¾ When measuring the urine, the sample aspiration and dispensation
repeats twice.
(7) Sample is down to the electrode unit position. Electro-motive force os
sample is read.
(8) Sample in the electrodes unit is discharged.
(9) The sample pot and the electrode unit are washed with Cal-1.
(10) The electro-motive force of Cal-1 in the electrode unit is read.
2-7

V1.00
2.3 Units and functions

2.3.1 Plane of the main units

The system is composed sampler, sample transfer mechanism, reagent
tray, reagent transfer mechanism, reaction tray, mixing units, cell
washing unit, spectrophotometer and so on.

2.3.2 Sample tray
A sample tray holds cups and tubes.

Sampler rotates a sample tray and transfers samples to the sampling
position.

2.3.3 Sampling transfer mechanism

Sample probe aspirates the designated volume of a sample from
a sample cup/tube and STM carries sample probe to the cuvette
position and the sample is dispensed into a reaction cuvette.
¾ The sample probe has a level sensor.

Sample probe is filled with washing water till tip.
When aspirating sample, the probe aspirate a small amount of air, and
then aspirates a little excess amount of sample, and dispenses designated
volume.
2.3.4 Reagent tray

When power is ON, these bottles are kept cooled.
Reagent tray holds reagent, diluent and cleaning solution bottles and
transfers them to the aspiration position.
2-8


2.3.5 Reagent transfer mechanism

Reagent probe aspirates the designated volume of reagent from a reagent bottle
and RTM carries the reagent probe to the cuvette position and the reagent is
dispensed into a reaction cuvette.
There are two reagent probes. R1 probe (for the 1st reagent) is at the washing
pot side and R2 probe (for the 2nd reagent) is at the opposite side, when
initialized.
¾ Reagent probe has a level sensor.
A reagent pump is commonly used for R1 and R2.
Reagent probe is filled with washing water till tip.
When aspirating reagent, the probe aspirate a small amount of air, and
then aspirates a little excess amount of reagent, and dispenses designated
volume.

2.3.6 Reaction tray and reaction cell

Reaction cuvette
Holds reaction cells at 37Celsius degrees, and lets sample and reagent
react. Reaction cells are optical cells to measure light absorption.
Reaction cell direct optical measurement

2.3.7 Mixing unit

By Dpplying reciprocal air pressure at one opening end of a cuvette, the
reaction liquid moves up and down, which causes good mixing.

Principle of mixing

2-9

V1.00
2.3.8 Cell washing station

Reaction cell washing mechanism

Perform reaction cell washing before start the measurement. The reaction
drainage after the test is removed and the cell is washed with cleaning
solution. The washing solutions are pre-heated.
1) Washing nozzle location

࣭For reaction drainage aspiration --------- 1 nozzle (Nozzle No.1 ‫)ۑ‬
࣭For cleaning sol. Aspiration ---------------- 7 nozzles (Nozzles No.2,3,5~9 ‫)ۑ‬
࣭For pure water aspiration ------------------ 2 nozzles (Nozzle No.10 ‫)ۑ‬
࣭For residual water droplet removal ----- 2 nozzles (Nozzle No.11 㸧
࣭For cleaning solution dispensation ------- 2 nozzles (Nozzles No.3, 5 )
࣭For pure water dispensation ---------------- 5 nozzles (Nozzles No.2, 6 ~ 9●)
2) Cell washing process

2-10


2.3.9 Spectrophotometer and measurement method
Measures optical absorption of 13 wavelengths of pure water and reaction

liquid in cuvettes while the reaction tray rotating.
1) General view of optical system

2) Measurement method
(1) White light emitted from the light source lamp is converged to a light beam.
(2) The light goes through the reaction cuvette.
(3) Then leads to a concave grating, so called the rear diffraction
spectrophotometry.
(4) After the diffraction, light energy is measured by 13 individual photo
detectors in each designed wavelength.
(5) For the monochromatic measurement, the output of one detector is taken
out of 13, and for the bi-chromatic measurement, two outputs are taken.
(6) These output voltages are converted into digital data and logarithmic
transformed, which is linearly corresponds with concentration.

3) Measurement characteristic
When the reaction tray rotates and the reaction cell passes the
optical measurement position, light absorption data are measured.
The optical absorptions are measured all the cycle.

2-11

V1.00
2.3.10 ISE Module (Option)

ISE module is used for measurement of ion concentration (Na+, K+, Cl+) in
the sample.

ISE Module

ISE piping diagram

2-12


2.3.11 HbA1c Sample preparation

HbA 1 c sample preparation(Hemolysis) is performed automatically.

HbA1c sample preparation flow (Hemolysis)

ᬅ Set the centrifugalized tube on the sample tray. (Fig ձ)
ᬆ Aspirates the red blood cell sample from the blood cell layer by sample
probe.㸦Fig. ղ㸧
ᬇ Reaction cell 1 (Sample preparation cell)
Dispense the lysing solution and blood cell sample. Prepare the hemolysis
sample by mixing.㸦Fig. ճ㸧
ᬈ Reaction cell 2
After reagent dispensation to reaction cell 2, aspirate the hemolysis
sample from reaction cell 1 and dispenses.
Continue the measurement.(Fig. մ)

ձ ղ ճ մ
Sample probe Mixing Sample probe

Hemolysis
Ћ Ѝ
Blood cell
Aspirates the red blood Hemolysis the red Aspirates the hemolysis
Centrifugal separate
cell sample and blood cell by mixing. sample and dispenses to
sample
dispenses to hemolysis cell 2.
cell l.
Tube Reaction cell 1 Reaction cell 2

(Preprocessing)
HbA1c sample preparation flow
2-13

V1.00
2.3.12 Sample clot detection

When the sample probe detects the clot by fibrin, perform the washing
automatically. The error flag “c” is attached to related result.

Solution flow after clot detection

(Sample probe)
Sample aspiration
Clot detection
㸦Automatic-cleaning 㸧
Sample probe moves to the
trough and wash 2 times.
࠙Clot is heavyࠚ
࠙Dissolve the clotࠚ
Can’t continue the measurement
Restart the measurement from the
next Item. ࠙Sampling stopࠚ
࠙End of runࠚ ࠙End of runࠚ
Clean up the sample probe.

Rerun of the clot detected Item.
(Maintenance required)
Refer to Chapter 5, Maintenance.
2-14


2.3.13 Probe crash detection

When the probe detects the clash, the movement stops immediately to
protecting the probe.

The probe crash detection is effect when the probe is down.
The probe movement stops by liquid level error instead of crash error in
next case.
¾ When the crashed thing includes water or water drop attach on the
surface. Confirm the crash, and remove it. Rerun the measurement.

2-15

V1.00
2.4 Analysis type

2.4.1 Kinds of analysis types
End assay Rate assay

One point end assay One point rate assay
Two points end assay 1 Two points rate assay 1

Measure the optical absorbance at the fixed time. Concentration
i or activity
i i iis calculated
l l d ffrom the rate
of absorption change.
One point end assay One point rate assay

Calculate the absorbance difference of the two Calculate the absorbance rate of two different
intervals, sub-interval and main-interval, and
different intervals, sub- and main-intervals.
calculate concentration or activity from the
difference between these two rates.

Calculate the absorbance rate of two different
intervals, sub-interval and main-interval, and
Calculate the absorbance difference of the two
calculate concentration or activity from the
different intervals, sub- and main-intervals. difference between these two rates.
2-16


2.4.2 One point end assay

Measure the optical absorbance at the fixed time after mixing the
reagent and the sample.

S 㸸 Sample dispensation
R1 㸸 1st reagent dispensation
R2 㸸 2ndreagent dispensation
R1+S 㸸 1st reagent + Sample
ABS 㸸 Optical absorbance
MAIN 㸸 Main-measurement
interval

One point end assay

1㸧Optical measurement points input
MAIN: 11 ӌ START ӌ END ӌ 54
2㸧Optical absorbance calculation for unknown sample

Ax : Absorbance of unknown sample
( ѷA㹊㸯㸫(R ѷA㹊㸰 )) AL1 : Absorbance of main-wavelength
Ax㸻 ̿̿̿̿̿̿̿̿̿̿̿ AL2 : Absorbance of sub-wavelength
N
N : Number of measurement points
R : Bi-chromatic factor (Default= 1)
3㸧Concentration calculation
Cx : Concentration of unknown
(Ax㸫Ab)
sample
Cx㸻̿̿̿̿̿̿ Cs
(As㸫Ab)
Ab : Absorbance of reagent blank
As : Absorbance of standard sample
Cs : Concentration of standard
Sample

2-17

V1.00
2.4.3 Two points end assay 1

Calculate the absorbance difference of the two different intervals,
sub- and main-intervals.
R1 : 1st reagent dispensation
R2 : 2nd reagent dispensation
R1+S : 1st reagent + Sample
ABS : Optical absorbance
MAIN : Main-measurement interval
SUB : Sub-measurement interval
T
Two points
i t end
d assay 1
MAIN : 34 ӌ START ӌ END ӌ 54
SUB : 11 ӌ START ӌ END ӌ 30
2㸧Optical absorbance calculation
( A㹊㸯㸫( R A㹊㸰 )) ( A㹊㸯㸫( R A㹊㸰))

Ax㸻 ̿̿̿̿̿̿̿̿̿̿ - K ̿̿̿̿̿̿̿̿̿̿
N MAIN n SUB

AL1 : Absorbance of main-wavelength
AL2 : Absorbance of sub-wavelength
N : Number of measurement points of main-interval
n : Number of measurement points of sub-interval
R : Bi-chromatic factor (default = 1)
K : Volume correction factor (Calculated automatically)
MAIN: Main-interval
SUB : Sub-interval

$[㸫$V/
&[㸻̿̿̿̿̿̿̿ &V+㸫&V/ 㸩&V/
$V+㸫$V/
Cx : Concentration of unknown sample

Ab : Absorbance of reagent blank sample
AsH : Absorbance of high value standard sample
AsL : Absorbance of low value standard sample
(When standard sample is one, Ab above is used in calculation.)
CsH# : Concentration of high value standard sample
CsL# : Concentration of low value standard sample
2-18


2.4.4 Two points end assay 2
Calculate the absorbance difference of two different intervals, sub- and

main-intervals.
Two points end assay 2

MAIN :SUBӌSTARTӌENDӌ 54
SUB :34ӌSTARTӌENDӌSTART

$㹊㸯㸫 5 $㹊㸰 $㹊㸯㸫 5 $㹊㸰

$[㸻̿̿̿̿̿̿̿̿̿̿㸫.̿̿̿̿̿̿̿̿̿̿

10$,1Q68%

AL1 : Absorbance of main-wavelength
AL2 : Absorbance of sub-wavelength
N : Number of measurement points of main-interval
n : Number of measurement points of sub-interval
R : Bi-chromatic factor (default = 1)
K : Volume correction factor (Calculated automatically)
MAIN : Main-interval
SUB : Sub-interval

$[㸫$V/
&[㸻̿̿̿̿̿̿̿
&V+㸫&V/ 㸩&V/

$V+㸫$V/

Ab : Absorbance of reagent blank sample
AsH : Absorbance of high value standard sample
AsL : Absorbance of low value standard sample
(When standard sample is one, Ab above is used in calculation.)
CsH# : Concentration of high value standard sample
CsL# : Concentration of low value standard sample
2-19

V1.00
2.4.5 One point rate assay

Concentration or activity is calculated from the rate of absorption
change.

MAIN: Main-measurement interval

One point rate assay

MAIN: 11ӌSTART< ENDӌ54

‫ڹ‬$[㸻 ‫ڹ‬$㹊㸯㸫‫ڹ‬$㹊㸰㸭PLQ

‫ڹ‬Ax : Absorbance rate of unknown sample
‫ڹ‬AL1 : Absorbance rate of unknown sample in main-wavelength
‫ڹ‬AL2 : Absorbance rate of unknown sample in sub-wavelength

Absorbance rate is calculated by the least squares method in the
given interval, and the rate is expressed by the absorption change
per minute.


&[㸻 ‫ڹ‬$[㸫‫ڹ‬$E )

‫ڹ‬Ax : Absorption rate of unknown sample
‫ڹ‬Ab : Absorption rate of reagent blank
F : Factor

2-20


2.4.6 Two points rate assay 1
Calculate the absorbance rate of two different intervals, sub-interval

and main-interval, and calculate concentration or activity from the

Two points rate assay 1

Main : 34 ӌ START ӌ END ӌ 54
SUB : 11 ӌ START ӌ END ӌ 30

$㹊㸯㸫 $㹊㸰 $㹊㸯㸫 $㹊㸰

$[㸻̿̿̿̿̿̿㸫.̿̿̿̿̿̿

PLQ0$,1PLQ68%


per minute.
‫ڹ‬AL2 : Absorbance rate of unknown sample in sub-wavelength
K : Blank correction factor (Need to input factor value manually)
SUB : Sub-interval

&[㸻 ‫ڹ‬$[㸫‫ڹ‬$E )

F : Factor
2-21

V1.00
2.4.7 Two points rate assay 2

Calculate the absorbance rate of two different intervals, sub-interval
and main-interval, and calculate concentration or activity from the

t : time

Two points rate assay 2

MAIN : SUBӌ START ӌ END ӌ 54
SUB : 34 ӌ START ӌ END ӌ MAIN


$㹊㸯㸫 $㹊㸰 $㹊㸯㸫 $㹊㸰
$[㸻̿̿̿̿̿̿㸫.̿̿̿̿̿̿
PLQ0$,1PLQ68%

per minute.
ᇞAL2 : Absorbance rate of unknown sample in sub-wavelength
K : Blank correction factor (Need to input factor value manually)
SUB : Sub-interval

&[㸻 ‫ڹ‬$[㸫‫ڹ‬$E )

F : Factor
2-22


2.5 Kinds of calibrations

- Linear 1 (Two points linear)
- Linear 2 (Multi-points linear)
- Factor
- Non-linear
1) Logit 1 2) Logit 2 3) Spline
4) Exponential 5) Polynomial

Linear 1 (Two points linear)࣭Linear1 Logit 2

Linear 2 (Multi-points linear)࣭Linear2 Spline

Factor Exponential

Logit 1 Polynomial
2-23

V1.00
2.5.1 Linear 1 (Two points linear)

One standard sample and a blank sample make a linear calibration line.
The “Linear 1 calibration” is applicable.
ABS 㸸Optical absorbance
Conc. 㸸Concentration
B 㸸Reagent blank
Ab 㸸Absorbance of reagent blank
Cb 㸸Concentration of reagent blank
Ax 㸸Absorbance of unknown sample
Cx 㸸Concentration of unknown
sample
S 㸸Standard sample
As 㸸Absorbance of standard sample
Linear 1 (Two Points Linear) Cs 㸸Concentration of standard
sample
1㸧Standard sample concentration input

Blank 㸸Input concentration of blank or lowest concentration of the
standard sample.
Standard㸯㸸Input standard sample concentration

2㸧Concentration calculation of end point assay
(Ax㸫Ab) sample
Cx㸻 ̿̿̿̿̿̿̿ Cs Ax : Absorbance of unknown sample
(As㸫Ab) Ab : Absorbance of reagent blank
As : Absorbance of standard sample
sample

3㸧Concentration calculation of rate assay
(‫ڹ‬Ax㸫‫ڹ‬Ab) sample
Cx㸻 ̿̿̿̿̿̿̿ Cs ‫ڹ‬Ax: Absorbance rate of unknown
(‫ڹ‬As㸫‫ڹ‬Ab) sample
‫ڹ‬Ab: Absorbance rate of reagent
blank
‫ڹ‬As: Absorbance rate of standard
sample
sample

2-24


2.5.2 Linear 2 (Multi-points linear)
Multiple standard samples (2-6) and a blank sample make a linear

calibration line.
The “Linear 2 calibration” is applicable.
ABS : Absorbance
Conc. : Concentration
B : Reagent blank
Cb : Concentration of reagent
blank
Ax : Absorbance of unknown
sample
sample
S1-Sn : Standard sample
Linear
2 (Multi-points Linear)

Blank 㸸Input the blank or lowest sample concentration.
Standard㸯㹼8 Input the standard sample concentration.
Inputting of maximum 8 standards is possible.
As# : Absorbance of standard sample#
Cs# : Concentration of standard sample#
(1) Ax ӌ As1
(Cs1㸫0)
Cx㸻(Ax㸫Ab)×―――――――
(As1㸫Ab)
(2) As1 ӌ Ax ӌ As2
(Cs2㸫Cs1)
Cx㸻(Ax㸫As1)×――――――― 㸩Cs1
(As2㸫As1)
(Cs3㸫Cs2)
(As3㸫As2)
2-25

V1.00
(Cs4㸫Cs3)
(As4㸫As3)
(Cs5㸫Cs4)
(As5㸫As4)
(Cs6㸫Cs5)
(As6㸫As5)

2-26


2.5.3 Factor

A blank sample and a given factor make a linear calibration line.
B : Reagent blank
blank
sample
Factor sample
1㸧Factor input
Input the value in factor box.
sample
Cx㸻(Ax㸫Ab) × F
sample
F : Factor
3㸧Concentration calculation of rate assay
sample
Cx㸻(‫ڹ‬Ax㸫‫ڹ‬Ab) F
‫ڹ‬Ax : Absorbance rate of unknown
sample
‫ڹ‬Ab : Absorbance rate of reagent
blank
F : Factor
4㸧Factor calculation
Tv 1 1
F 㸻 ̿̿̿ ̿̿̿ ̿̿̿̿̿̿ 10㸴
Sv L (Ȝ1㸫Ȝ2)

Tv : Total volume (micro-liter)㸻Sample volume x Dilution ratio㸩
Reagent volume
Sv : Sample volume (micro-liter)
L : Optical length (default㸻10 mm)
The measured optical absorption data are converted to
10 mm optical lengths by system software.
Ȝ1 : Substrate molar light absorption coefficient (1/mol.cm) at
main wavelength.
Ȝ2 : Substrate molar light absorption coefficient (1/mol.cm) at
sub-wavelength.
2-27

V1.00
2.5.4 Non-linear

This logic makes the approximate curve using 2-6 standard sample
s including a blank sample, as a calibration curve. There are the
following five types.

4-1. Logit 1
This logic is used for the calibration curve in which the absorbance
converges to the increase of concentration.

ABS : Absorbance

B : Reagent blank

Ab : Absorbance of reagent
blank

blank

sample

sample
Logit 1
A1-An : Absorbance of standard
sample
C1-Cn : Concentration of standard
sample
Maximum 8 standards are possible.
sample
Cx㸻 (C㸩Cb) Ax : Absorbance or absorbance
rate of unknown sample
Cb : Concentration of reagent blank
K
Ab : Absorbance or absorbance rate
Ax㸻Ab㸩̿̿̿̿̿̿̿̿̿̿̿ of reagent blank
(1㸩exp(-a-blnC)) K, a, b : Constants
(Calculated automatically㸧
1 Ax㸫Ab

C 㸻 exp ̿̿ (ln ̿̿̿̿̿̿̿ 㸫 a)

b K㸫(Ax㸫Ab)

When Cx is being ∞, close to Ax㸻K㸩Ab.
When K 㸼0 and ӌ Cb, C㸻0.
When K 㸺0 and Ax Ӎ Cb, C㸻0.
2-28


4-2. Logit 2
This logic is used for the calibration curve in which the absorbance
converges to the increase of concentration.
As this logic uses more parameters than logit.log 1, better approximation
may be expected.
ABS :
Absorbance
Conc. :
Concentration
B :
Reagent blank
Ab :
Absorbance of reagent blank
Cb :
Concentration of reagent
blank
sample
sample
Logit 2 sample
sample
Two standard samples are essential

Cx㸻 (C㸩Cb) sample
Ax : Absorbance or absorbance rate
of reagent blank
Cb : Concentration of reagent blank
Ab : Absorbance or absorbance rate
of reagent blank
K, a, b, c : Constants
(Calculated automatically)
K

Ax㸻Ab㸩̿̿̿̿̿̿̿̿̿̿̿̿̿

(1㸩exp(-a-blnC-cC))

(Ax㸫Ab)
0 㸻a㸩blnC㸩cC㸫 ln ̿̿̿̿̿̿̿̿̿
(K㸫(Ax㸫Ab))
Calculate C by Newton approximation method
When Cx is being ∞, close to Ax㸻K㸩Ab.

When K 㸼0 and ӌ Cb, C㸻0.
When K 㸺0 and Ax Ӎ Cb, C㸻0.
2-29

V1.00
4-3. Spline
Connect absorption data of #I to #I+1 standard samples (I = 1 - n),

taking into the account of the data of #I-1 and #I+2 and adjust to make a
smooth calibration curve.
ABS : Absorbance
B : Reagent blank
blank
sample
A1-An: Absorbance of standard
Spline sample
C1-Cn: Concentration of standard
sample
Two standard samples are essential
Cx㸻 (C㸩Cb) sample
Ax : Absorbance or absorbance
blank
Ab : Absorbance or absorbance
rate of reagent blank

Ax㸻a(I)+b(I)㺃(C-C(J))+c(I)㺃(Cx-C(J))㸰+d(I)㺃(C-C(J))㸱
a(I),b(I),c(I),d(I): Constants (Calculated automatically)

I=1㹼N

f(C-C(J))=a(I)+b(I)㺃(C-C(J))+c(I)㺃(C-C(J))㸰+d(I)㺃(C-C(J))㸱-Ax
Increasing type a(1) ӌ a(N) and a(1) Ӎ Ax then C=C1

Decreasing type a(1) Ӎ a(N) and a(1) ӌ Ax then C=C1
2-30


4-4. Exponential

For being different from 4-1,4-2,4-3 above, this logic is used for the
calibration curve in which the absorbance diverges to the increase of
concentration.
ABS : Absorbance
B : Reagent blank
Ab : Absorbance of reagent
blank
blank
sample
Exponential sample
A1-An: Absorbance of standard
sample
C1-Cn: Concentration of standard
sample

One standard sample is essential

Cx 㸻 (C㸩Cb) sample
Ax 㸻 Ab + K㺃exp(a㺃(lnC) + b㺃(lnC)㸰 + c㺃(lnC)㸱)
K,a,b,c : Constants (Calculated automatically)

Ax-Ab
a㺃(lnC)+b㺃(lnC)㸰+c㺃(lnC)㸱 - ln ̿̿̿̿ =0
K
When .㸼and$[ӌ$E, &㸻

2-31

V1.00
4-5. Polynomial

This calibration curve is used for the case which optical absorbance
decreases as concentration increases.
ABS : Absorbance
B : Reagent blank
blank
sample
sample
Polynomial S1-Sn : Standard sample
sample
sample.

One standard sample is essential

Cx 㸻 (C㸩Cb) sample
blank
C 㸻 K +㸦aAx㸧+ (bAx㸰 ) + (cAx㸱)
K,a,b,c : Constants (Calculated automatically)

2-32


2.6 ISE Module (Option)

ISE (ion selective electrode) measures electro-motive force (mV), induced by ion
concentration in the sample.
Four kinds of electrodes are used for the system.

Na electrode : Sensitive only for Na ion in the sample.
K electrode : Sensitive only for K ion in the sample.
Cl electrode : Sensitive only for Cl ion in the sample.
Reference electrode : No ion selectivity

2.6.1 ISE Calibration
1) Two points calibration (Calibration measurement)

Two points calibration is done every morning, before the system starts to operate.
Calibrator-1(Cal-1) and Calibrator-2 (Cal-2) are measured and the slope,
ion concentration versus mV, is calculated for each item.
¾ If the slope is out of the standard range, below, the electrode should be
replaced. If the slope of all electrodes is out of range, reference electrode
should be checked.
Please refer to Chapter 6 Alarm.

Slope range (mV/) Range (mmol/L)
Serum Urine Serum Urine
Na 30.37-73.40 30.37-73.44 100-200 10-400
K 29.45-69.46 29.46-69.46 1-10 1-200
Cl 21.01-68.71 21.01-68.71 70-200 30-400

2) One point calibration (Patient sample measurement)
One point calibration is done for each test.
For each test, both sample mV and Calibrator-1( Cal-1 ) mV are measured, and
correlate the measurement condition.

2.6.2 ISE Concentration calculation

Ca : Concentration of Cal-1
Cx = Ca * 10^ [(Ex – Ea) / S] Ex : Electromotive force of unknown sample
Ea : Electromotive force of Cal-1
S : Slope, measured by two points calibration.

2-33

V1.00
2.7 Linearity check

To determine if a curve is linear, a linearity check will be calculated after each
rate assay.
The “L” flag appears when that check exceeds the preset value.
L1 : Main wavelength
L2 : Sub wavelength
‫ڹ‬A1 : The slope of measuring
range 1
‫ڹ‬A2 : The slope of measuring
range 2
‫ڹ‬A : The slope of the total curve

Linearity check
1) Parameter setting
Input the Linear Check(%) in Item parameter screen (above zero).
2) Calculation Formula
Linearity check(%) 㸻 (ǼA1 㸫ǼA2) / ǼA㹶 100%
ǼA1 The slope of the first half of the curve

(using a least-squares method.)
ǼA2 The slope of the second half of the curve
ǼA The slope of the range of measuring A
2-34


2.8 Prozone check

This function checks if there is a Prozone phenomenon in immunoassay.
Based on the registered parameter, this function checks the curvature of
reaction diagram up to 2 zones, and if Prozone is detected, puts the data
message flag “P” on the printout data.
࣭Prozone phenomenon㸸The high conc. result shows lower result cause of the
special immunological reaction.

S 㸸Sample dispensation
R1+S 㸸1st reagent 㸩Sample
R2 㸸2nd reagent dispensation
ABS 㸸Optical absorbance
FIRST 㸸Interval(1)
SECOND㸸Interval(2)
Use main wavelength
Prozone check

1) Prozone check value setting.
Input the Prozone check conditions in Item parameter setting column.
(1) First interval- Start, End : Starting and ending test points of basic test
interval.
Second interval-Start, End: Starting and Ending test points of second
interval.
Input range is 34 – 54 point.
(2) Limit value: Input the comparison limit value(%).
(3) High, Low: Select the check high or low.

2) No Prozone check condition setting.
Input the no Prozone check condition (minimum Abs. of average, minimum slope
value) in Item parameter Prozone setting column.
(1) Minimum Abs. average value: Input the first interval value.
(2) Minimum slope value: Input the first interval value(ԥOD/min).

¾ No Prozone check is done if the average or slope value exceeds the input
value.
¾ No Prozone check is done if no input the check value or the slope value of
the first interval is below zero.
3) Calculation formula
The second check value ΔOD2㸭ΔOD1㸨100(%)
ǼOD1 The gradient in the first interval
ǼOD2 The gradient in the second interval
2-35

V1.00
2.9 Serum information (L-H-I)
The Lipemia, Hemoglobin and bilirubin which included in serum sample is influenced
the result.
The serum information measures the Lipemia, Hemoglobin, Bilirubin (L-H-I), and
judges the level of it.
The serum information result makes the judgement based on the information results.
Affect the measurement result. Lipemia(L)㺃Hemolysis(H)㺃Bilirubin(I).

Serum information check method
Lipemia(L)
Measures the two wavelengths in the wavelength rang of visible light.
(No effect of hemolysis and bilirubin)
Hemoglobin (Hemolysis࣭H)
Measures the two wavelengths in the medium wavelength region
(No effect of bilirubin). And measure the two wavelengths in the
long wavelength region.
Bilirubin (Icteric࣭I)
Measure the two wavelengths in the short wavelength region.
And measure two wavelengths of medium and long-wavelength region.

Measurement preparation and method
The serum information Item (L-H-I) is fixed in the program. Prepare the saline
bottle to measure the serum information. (Bottle condition and setting)
*Order entry and measurement is same as other Items. Please refer to
Chapter 3 Operation for details.
Item setting and result Operation

The serum information is set as default.(L-H-I)
Item parameter setting ¾ Condition setting of concentration result
transforms to qualitative result.
ձ The reagent bottle position set in reagent screen
Reagent setting(Position) for Item [L-H-I].
ղ Set the saline bottle on the reagent tray.
Calibration No necessary
Order entry Order by selection of [L-H-I].
Measurement Use saline as a reagent.
Display value in results column, and judgement of㸩㸫
is shown in qualitative column by the Item parameter
setting.
Result ¾ L : Lipemia, H: Hemoglobin, I:Bilirubon
¾ If there is a decision the difference between
serum information by visual, please adjust by
changing the decision value.
2-36


2.10 Carryover avoidance

As sample probe, reagent probes and reaction cells contact with different kinds
liquid and sometimes built-in cleaning process is not sufficient.
It may cause carryover. To avoid these kinds of carryover, it is possible to do
special cleaning by carryover protection function.

2.10.1 Kinds of carryover avoidances

1. Reagent probe cleaning
After the aspiration of proceeding reagent, analyzer aspirates cleaning solution
instead of reagent and dispenses into empty cell and washed.

2. Sample probe cleaning
After the aspiration of proceeding sample, sample probe aspirates cleaning
solution instead of sample and dispenses into empty cell.
There are 3 kinds of sample probe cleaning, between Items, samples and
sample kinds. One kind of sample probe washing registration is possible.

3. Reaction cell cleaning
A reaction cell used for registered reagent is not used for test at the next
cycle. Reagent probe dispenses cleaning solution into the cell and washed.

2-37

V1.00
2.11 Automatic start-up, shut down and automatic maintenance

By the combination of automatic start-up, shut down and maintenance,
shorten the performance time when start-up and shut down the analyzer.
2.11.1 Automatic start-up and shut down
By using the auto-start and shut down setting, analyzer power switch is
ON or OFF automatically at the time, which is set by the timer for weekly day.

2.11.2 Automatic maintenance

By the setting of automatic maintenance, perform the maintenance before and
after system power OFF or ON automatically. The function is able to set by the
timer for weekly day.
2-38

Chapter 3
Explanation of each screen and operating condition
3.2 Software program installation....................................................................................... 3-2

3.2.1 PC specification ...................................................................................................... 3-2
3.1.2 Install CD information............................................................................................. 3-2
3.1.3 Installation procedure.............................................................................................. 3-2
3.3 Routine operation flow .................................................................................................. 3-3
3.3.1 Start-up inspection ................................................................................................. 3-5
3.3.2 Start-up㸦Analyzer power switch ON㸧................................................................. 3-6
3.3.3 Analyzer initialization㸦Ready㸧 ........................................................................... 3-7
3.3.4 Measurement condition (Item parameter) setting.................................................. 3-8
3.3.5 Reagent bottle position setting ............................................................................... 3-9
3.3.6 Reagent bottle setting........................................................................................... 3-10
3.3.7 Calibration setting (Standard sample position, concentration) ............................ 3-11
3.3.8 Calibration order entry......................................................................................... 3-13
3.3.9 Calibration sample setting (Blank, Standard) and measurement ........................ 3-14
3.2.10 ISE Calibration sample setting and measurement .............................................. 3-16
3.3.11 Calibration result confirmation............................................................................ 3-18
3.3.12 QC measurement condition setting (Control setting) .......................................... 3-20
3.3.13 QC sample order entry......................................................................................... 3-21
3.3.14 QC sample setting and measurement .................................................................. 3-22
3.3.15 QC sample result confirmation ............................................................................ 3-24
1. Current QC screen ................................................................................................... 3-24
2. QC History screen .................................................................................................... 3-26
3.3.16 Patient sample order entry .................................................................................. 3-28
3.3.17 Patient sample setting and measurement ........................................................... 3-30
3.3.18 Patient result confirmation.................................................................................. 3-32
1. Result screen ............................................................................................................ 3-32
2. Result Log screen ..................................................................................................... 3-33
3. Patient Result screen ............................................................................................... 3-34
4. Data List screen ....................................................................................................... 3-35
3.3.19 Inspection and maintenance at the end of operation ........................................... 3-36
1. Caution .................................................................................................................... 3-36
2. Inspection and maintenance .................................................................................... 3-36
3.3.20 Shutdown .............................................................................................................. 3-37

3-1

V.1.00
3.1 Software program installation
The analyzer is used exclusive software program. Please install the program by
attached CD.
3.1.1 PC specification
¾ Refer to Chapter 1, 1.2.7. PC (LAN cable) for PC specification.
3.1.2 Install CD information
¾ Install the database and system program by install CDs.
3.1.3 Installation procedure
1) Insert the CD to PC driver.

2) Installation starts automatically.
3) Continue the installation under the “Wizard”.
If some dialog box appeared cause of the Windows security, ensure “YES”.
4) Select the installation language.
5) Click “Install” button.
6) Proceed by clicking “Next” and “Agree” buttons.
7) Input analyzer serial number, select default language and analyzer name.
8) Click “Next” button.
9) Click “Install” button.
10) Click “Finish” button. The installation completed.
¾ In case of version up: Install the version up CD.

The uninstallation is unnecessary.
3-2

3.2 Routine operation flow
¾ Routine operation (from start up to shutdown) follows the procedure steps.

¾ The operation flow includes unnecessary settings on each time. Please operate
according to the requirement.
ձЍ
Ћչ

Ћպ
Ћյ “QC Start” button shows in
Ћշ QC screen instead of “Start”
button.
Ћմ
ոЍ
Ћճ
նЍ
ղЍ
Ћջ
Main screen
Step Button & Screen Operation
1 ― Start-up inspection.
Icon Start up the analyzer
(Analyzer ¾ Turns on the PC power switch, and start up the system
2 ձ
system program. Turns on the analyzer main switch and system
switch) switch.
3 ղ Ready Analyzer initialization
Setting of Item parameters (Item name, wavelength, sample
4 ճ Item
volume and reagent volume)
5 մ Reagent Setting of reagent position.
6 ― Set the reagent bottle on the reagent tray.
7 յ CAL Setting of calibration (Calibrator position, concentration).
8 յ CAL Order entry of calibration sample.
Set the calibration blank and standard sample on the sample
9 ն Start
tray. Start the calibration measurement.
10 յ CAL Confirmation of calibration results.
11 շ QC Setting of QC sample measurement (Control setting)
12 շ QC Order entry of QC sample.
Set the QC sample on the sample tray.
13 ո QC Start
Start the QC sample measurement.
3-3

V.1.00
Step Button & Screen Operation
14 շ QC Confirmation of QC sample results.

15 չ Order Order entry of patient sample.
Set the patient sample on the sample tray.
16 ն Start
Start the patient sample measurement.
17 պ Result Confirmation of patient sample results.
18 ― Shutdown inspection and analyzer maintenance.
Icon
Shutdown the analyzer.
(Analyzer
19 ձ ¾ Turns off the system switch, and close the system program.
system
Turns off the PC switch and analyzer main switch.
switch)
3-4

3.2.1 Start-up inspection
¾ Confirmation of the following points before starting the analyzer. Perform the reagent
refill or other requirement.
Step Inspection
1 No obstruction for analyzer movement (Sample probe and Reagent probes)?

Confirmation of water supply.
2 ¾ Is de-ionized water enough in the water reservoir?
¾ Open the water supply line on the water purification system?
Confirmation of cleaning solution reservoir.
3 ¾ Are the Alkaline and Acid cleaning solutions enough in the cleaning solution
reservoir?
Confirmation of drainage reservoir.
4
¾ Are the waste tank and separate waste tank empty?
Confirmation of residual reagent.
5
¾ Are the reagents enough?
¾ When analyzer is attached the ISE unit, add the following inspection.
6 Is the ISE Calibrator 1 enough?
7 Is the ISE drainage tank empty?
3-5

V.1.00
3.2.2 Start-up㸦Analyzer power switch ON㸧
¾ Start up the analyzer. Analyzer stand-by after power on follows the procedure steps.
Analyzer “stand-by” means?㸸The reaction tray temperature reaches 37 Celsius degrees.

ЌЌ Ќ

ձղ ճ

Main screen
Step Button & Screen Operation & Display
Turns on the analyzer main switch.

1 ―
¾ The main switch is left rear side on the analyzer.
2 ― Turns on the PC power switch.
3 (PC screen) Confirmation of Main screen.
4 ձ Status monitor ¾ Indicates [OFF LINE].
Temperature
5 ղ ¾ Indicates [---].
control monitor
Icon
Click power switch ON/OFF Icon.
6 ճ (Analyzer system
¾ Turns on the Analyzer system switch.
switch)
Starts the connection between the PC and analyzer.
¾ Confirmation of popup screen message.
7 ―
[Connecting] →[Program Downloading] →[Parameter
Downloading]
8 ― The connection between the PC and analyzer completes.
9 ձ Status monitor ¾ Indicates [IDLE].
Temperature
10 ղ ¾ Indicates [WARM-UP].
control monitor
11 ― Wait until the reaction temperature reaches 37 Celsius degrees
Temperature
12 ղ ¾ Indicates [OK].
control monitor
13 ― The analyzer stays stand-by.
3-6

3.2.3 Analyzer initialization㸦Ready㸧
¾ Initialize (Ready) the analyzer. For analyzer stand-by (Ready), follows the procedure
steps.
Analyzer initialization means? 㸸All the analyzer units move to home position (start
position).
Analyzer stand-by (Ready) means? 㸸All the analyzer units stay at home position (start
position).
Ќ

ղ

ձЍ

Main screen
1 ձ Ready Click “Ready” button.

Analyzer starts the initialization.
2 ― ¾ All of the analyzer units move to home position
(Start position).
3 ղ Status monitor ¾ When the analyzer is initializing, indicates [INIT].
4 ― Analyzer initialization completes.
5 ղ Status monitor ¾ Indicates [READY] after initialization.
Analyzer status stays stand-by (Ready).
6 ― ¾ All of the analyzer units stay at home position (Start
position).
3-7

V.1.00
3.2.4 Measurement condition (Item parameter) setting
¾ For measurement setting (Item parameter) follows the procedure steps.

¾ Please refer to Chapter 4, 4.6 Item screen of the other Item screen (except Optical
screen).
Ќ Ќ ղ
ճ

մ
Ћձ

Ћ յ
Ў

ձ

Item screen – Optical
Item
screen
Ћձ
Ћ

ձ

Step Button& Screen Operation & Display

1 ձ Item Click“Item” button.

Ћձ
2 (PC screen)
Item screen
is shown.

Optical

Item

ISE㸦Na,K,CL㸧

3 ղ Select
HbA1c the measurement
Item button.
Ћ

Calculation
Item ձ
Other

4
(PC screen) Selected Item screen is shown.

5 ճ Item No. ▼ Select Item number.

Select or Input the measurement parameter.

¾ In case of optical screen, following selection and

inputting are essential.
(Input measurement ࣭Item name ࣭Specimen

6 մ
conditions) ࣭Data Information ࣭Analysis

࣭Correlation ࣭Blankvalue

࣭Calibration ࣭Aspiration volume

࣭Data process ࣭K factor
7 յ Save Measurement settings are stored.
3-8

3.2.5 Reagent bottle position setting
¾ When using the reagent barcode, please refer to “Reagent barcode manual”.
¾ Please refer to Chapter 4, 4.6 Reagent screen for details.
¾ Reagent bottle setting in “Reagent Setting” screen follows the procedure steps.
Ћղ
Ќ
ճ

յ

Ћ ձ մ

ն

Ў

Ћձ

Reagent screen - Reagent Setting screen

Ћ

ձ
Step Button & Screen
Operation & Display

Ћ
1 ձ
ЋձReagent Click “Reagent” button.
ձ
Ћ
(PC screen)
2 Reagent screen is shown.
ձ
3 Reagent
ղ setting
Click
“Reagent
Settings”
button.

4 (PC
screen)
“Reagent
Settings”
screen
isshown.

Setting of “Reagent round”. Ћ
Round
name㸸
▼

5 ճ ¾ Click ▼ button, and select the round
ձ number.
㸦Round name㸧
Input “Round name”.

Setting of reagent bottle position.

6
մ 㸦1 㹼 36㸧 ¾ մ Select bottle position number from 1㹼36.
յ 㸦Item name㸧 ( Back color of selected column toblue)
turns

¾ յ Select the Item name from right side list.

Confirm the bottle position.

7 մ 㸦1㹼36㸧 ¾ Display the Item name at lower part for each 1㹼36

bottle positions.

8 ն Save Bottle settings are stored.

3-9

V.1.00
3.2.6 Reagent bottle setting

¾ Please refer to Chapter 4, 4.6 Reagent screen for details.
¾ Reagent bottle setting in “Bottle Info” screen follows the procedure steps.

Ћղ
Ќ
ճ

մ
Ћ ձ

յ ն

Ў Ў

Ћձ

Reagent screen – Bottle Info screen

Ћ

Ћձ ձ

Step
Button & Screen Operation & Display

1 ձ ЋձReagent
Click
“Reagent”
Ћ button.

2 (PC
screen)
Reagent
screen
ձ
is
shown.

3 ղ
Bottle
Info.
Click
“Bottle
Info”
button.

(PC
screen)
Bottle
Info screen
is shown.
4
name㸸
Round

round”.
Ћ

Select “Reagent ձ
5 ճ ▼
name㸧 ¾ Select the bottle setting round.
㸦Round

the reagent bottle positionand setting.

Confirmation of

6 մ

( 1㹼36㸧
¾ Reagent tray, position and Item name etc..

7 ― Set the reagentbottle which is confirmed in step
6.

Set the reagent
remaining.

Reagent remain is updated automatically by calculation of
measurement condition.
Fill Fill㸻Residual test number are renewed automatically.

8 յ ࣭Click Fill after Item selection.
Fill All Fill All㸻All reagents are renewed automatically.
¾ In case of ͆Level sensor͇ setting, reagent remain is

updated by reagent probe movement.
9 ն Save Reagent bottle setting (Reagent residual volume) is stored.
3-10

3.2.7 Calibration setting (Standard sample position, concentration)

¾ Input calibration measurement condition (Standard sample position,
concentration) in ”CAL -Calib . Settings” screen.
¾ Setting of the ISE Items are unnecessary. Tray and standard positions are fixed.

Ћձ ղ Ѝ

CAL screen

¾ Display
Ћձof Calibration setting screen follows 1-4 steps. Ћձ


1 ᬅ CAL
Click
“CAL”
button.

2 (PC screen) CAL screen is shown.

3 ᬆ Calib. settings Click “Calib. settings”
button.
4 (PC screen)

CAL-Calib. settings screen is shown.

ճ մ յ

շ

ն ո Ѝ

չ Ѝ

CAL-Calib. Settings screen

3-11

Ћ Ћ
Ћ
Downloaded from www.Manualslib.com manuals search engine ձ ձ ձ

V.1.00
¾ Setting of Calibration measurement in Calib. Settings screen follows the procedure

steps.
5 ᬇ Item name Select “Item name”.

6 ᬈ Specimen: ‫ۂ‬ Select “Specimen”.
Select using calibration tray for measurement.
7 յ Tray
¾ ISE calibration tray is fixed to C1.
Setting of calibrator position and concentration.
In box ¾ ISE calibrator positions are fixed.
¾ Position Setting of calibration measurement.
8 ն
¾ Asp. ¾ Select position of “Blank” and “Standard sample”
¾ Conc. ¾ Select repetition number.
¾ Input concentration of blank and standard sample.
In box Setting of calibration blank sample Abs. range.
¾ Lower limit Abs. ¾ Input lower limit Abs. for blank sample.
9 շ ¾ Upper limit Abs. ¾ Input upper limit Abs. for blank sample.
When blank sample is out of range, error displays.

No check if the setting is zero.
10 ո Save Calibration setting is stored.
Close the Calib. Settings screen and return to CAL
11 չ Exit
screen.

3-12

3.2.8 Calibration order entry

¾ Calibration order entry in “CAL” screen follows the procedure steps.

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CAL screen
1 ձ CAL Click “CAL” button.

3 ղ Specimen㸸 ▼ Select “Specimen”.
Order entry of calibration by Item selection.
¾ Order status turns to blue for blank order or dark
blue for general calibration.
Check the box ‫ ܇‬for each Item.
Blank order ‫ڧ‬
ճ ¾ Blank Order㸻Order entry of blank sample only.
Order ‫ڧ‬
¾ Order = Order entry of blank and standard sample.
մ Blank order ‫ڧ‬ Click Blank Order or Order button, and select ”Profile
4
Order ‫ڧ‬ name” or Select All.
¾ Blank Order㸻Order entry of blank sample only.
¾ Order = Order entry of blank and standard sample.
յ In box Select profile Items.

( Profile name)
ն Select All Select all the displayed Items.
5 շ Save Calibration order entry is stored.

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V.1.00
3.2.9 Calibration sample setting (Blank, Standard) and measurement

¾ Calibration blank and standard sample setting and measurement follows the
procedure steps. For ISE item, refer to Chapter 3, 3.2.10 ISE calibration sample
setting and measurement.

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CAL screen

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Main screen 㸫CAL tray selection
3-14

1 ᬅ CAL Click “CAL” button.

3 ᬆ Specimen: ‫ۂ‬ Select “Specimen”.
Confirmation of calibration order entry.
ᬇ ¾ Blank order/Order ¾ Order status turns to dark blue for blank and
standard sample or blue for blank sample in Item
box ‫܇‬.
4 մ ¾ Tray ¾ Tray number.
In box ¾ Measurement position and repetition number
upper parts from Blank to Standard 8 positions.
Upper parts Left side of hyphen shows measurement position.
Position-repetition Right side of hyphen shows repetition number.
5 ᬉ Main Click “Main” button.
6 (PC screen) Main screen is shown.
7 ᬊ CAL tray Icon (Yellow) Click “CAL “ tray Icon.
8 ᬋ CAL tray Icon (Yellow) CAL tray screen is expanded.
Select tray number which selected in step 3 by
9 ᬌ CAL tray Icon (Yellow)
clicking ‫ ۆ‬or ‫ ڼ‬button.
¾ Back color of ordered sample turns to blue in tray
position.
10 ―
Set the blank and standard sample which confirmed
in step 4 on the tray.
11 ᬍ Start Click “Start” button.
12 ― Starts the calibration measurement.
When the analyzer is running→ Indicates [RUN]
13
ᬎ Analyzer status monitor After sampling stop →Indicates [S.STOP]
14 After calibration completed→ Indicates [END]

Note:
¾ When calibrate the different specimen, please order and save for each specimen.
All of the ordered specimen perform the calibration measurement.
¾ When using the Item No.106 of HbA1c, please order both of Item No. 107 and 108 for
calibration measurement.

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V.1.00
3.2.10 ISE Calibration sample setting and measurement

¾ ISE calibration for plasma sample is unnecessary. Serum sample calibration is used.
¾ ISE calibration sample setting and measurement follows the procedure steps.

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CAL screen

մ
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Main screen 㸫CAL tray selection
3-16


3 ղ Specimen: ‫ۂ‬ Select “Specimen”.
Confirmation of calibration order entry.

4 ճ In box
¾ Order status turns to blue.
5 մ Main Click “Main” button.

7 յ CAL tray Icon (Yellow) Click “CAL “ tray Icon.
8 ն CAL tray Icon (Yellow) CAL tray screen is expanded.
9 շ CAL tray Icon (Yellow) Select tray number C1 by clicking ‫ۆ‬ or ‫ ڼ‬button.
Set the Calibrator cup (250uL) on the tray.
¾ Back color of ordered sample turns to blue in tray
position.
ISE calibration positions are fixed in program.
10 ― ISE C1= (for serum) Calibrator A
ISE C2㸻(for serum㸧 Calibrator B
ISE U1㸻(for urine ) Urine calibrator 1.
ISE U2 = (for urine) Urine calibrator 2
ISE D = (for dialysis) Dialysis calibrator
11 ո Start Click “Start” button.
12 ― Starts the calibration measurement.
13
չ Analyzer status monitor After sampling stop→ Indicates [S.STOP]
14 After calibration completed→ Indicates [END]

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V.1.00
3.2.11 Calibration result confirmation

¾ Confirmation of Calibration result in CAL screen.
¾ Please refer to Chapter 4, 4.4 CAL screen for details.

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CAL
screen

CAL screen ― Display of former Calibration results


3 ᬆ Specimen: ‫ۂ‬ Select “Specimen”.
Confirmation of calibration result.
Absorbance results
ᬇ In box
¾ The Absorbance value displays lower part from
Blank to Standard 1-8.
մ ‫ڧ‬Old Data Former results
¾ Check the Old data box □, select the Item name.
Display result graph
ᬉ Graph
3 ¾ Display graph screen of selected Item.
ISE results
ᬊ In box ¾ Display of latest results.
շ ISE graph ¾ Display of graph or list of former results.
Display of calibration result for details.
¾ When ISE calibration result is out of graph, the
ᬌ Cal Data
calibration is an error. Need to try re-calibration
measurement.
3-18

¾ Please refer to Chapter 4, 4.4 CAL screen for calibration graph and results.

յ

CAL screen―Graph screen

շ

CAL screen―ISE Graph screen (When result is out of range, the graph is not displayed.)

ո

CAL screen―Cal Data screen
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V.1.00
3.2.12 QC measurement condition setting (Control setting)

¾ Setting of QC measurement (QC sample name, measurement position, mean) follows
the procedure steps.
¾ Please refer to Chapter 4, 4.5 QC screen for details.

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ո

QC screen―Controls
Settings
screen

1 ᬅ QC Click “QC” button.

2 (PC screen) QC screen is shown.
3 ᬆ Control settings Click “Control Settings” button.
4 (PC screen) Control settings screen is shown.
5 ᬇ Control name: ▼ Select Item number and input control name.
Setting or input of QC measurement.
ᬈ Specimen: ▼ Select “Specimen”.
ᬉ Lot No. Input Lot number of QC sample.
Check the box ࣞ when input the expire date.
ᬊ Exp. date:‫_ ڧ‬ _▼
Select QC sample expire date in calendar date.
Pos.1㸸▼ - ▼ Select QC sample tray and position.
6
ᬋ 㹼 ¾ Left side of hyphen shows sample tray.
Pos.6㸸▼ - ▼ Right side of hyphen shows sample position.
Setting of QC sample profile.
ᬌ Profile‫ڧ‬ ¾ Check the box ࣞ to setting the QC profile order.
(Ordered sample turns to blue.)
Input control values (Mean, SD, Max and Min).
չ Mean, SD, Min, Max
¾ Min and MAX±2SD are calculated automatically.
Delete QC sample setting (profile) is deleted.
7 ᬎ
Save QC sample setting is stored.
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3.2.13 QC sample order entry

¾ Order entry of QC sample in ͆Order QC͇ screen follows the procedure steps.

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QC screen― Order QC screen

1 ձ QC Click “QC” button.

3 ղ Order QC Click “Order QC” button.
4 (PC screen) Order QC screen is shown.
Select QC sample measurement Item.
ճ Control: ▼ Select QC sample name.
Select measurement position (Sample tray㸫 sample
մ Position : ▼
position).
5 յ 㸡of Asp: ▼ Select repetition number.
Confirmation of order entry.

In box
ն ¾ Profile setting Items are ordered automatically.
( Item name)
¾ Back color of ordered Item turns to blue.
6 շ Order Order entry of QC sample measurement.

¾ After order entry, display next “Order QC” screen
automatically.
¾ When continue the order, follows the step 5 to 6.
Confirmation of QC sample order entry
ո Sample states㸸
Display the “Order”.
7
When order the multiple QC samples, confirm the order
չ ‫ۆ‬ ‫ڼ‬
by clicking ‫ ۆ‬or ‫ ڼ‬button.
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V.1.00
3.2.14 QC sample setting and measurement
¾ QC sample setting on the sample tray and measurement follows the procedure steps

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QC screen― Order QC screen


2 (PC screen)㸧 QC screen is shown.
3 ղ Order QC Click “Order QC” button.
4 (PC screen) Order QC screen is shown.
Confirmation of QC sample order entry.
ճ In box
Sample state㸸 ¾ Display “Order”.
¾ Confirm of all the order entry by clicking ‫ۆ‬ or
‫ ڼ‬button.
մ In box
5 Control : ▼ ¾ QC sample name.
Position : ▼ ¾ Measurement position.
Left side of hyphen shows sample tray.
Right side of hyphen shows sample position.
㸡of Asp : ▼ ¾ Repetition number.
Select tray Icon which confirmed in step 5.

Patient tray㸻Gray
6 յ Tray Icon
Calibration tray㸻Yellow
QC sample tray㸻Pink

3-22

Select tray number which confirmed in step 5 by

7 ն Tray Icon ‫ۆ‬ ‫ڼ‬ Patient tray㸻1㹼50
Calibration tray㸻C1㹼C6
QC sample tray㸻Q1㹼Q3
¾ Back color of ordered sample turns to blue in
tray position.
8 ―
Set the QC sample which confirmed in step 5 on the
tray.
9 շ QC Start Click “QC Start” button.
10 ― Starts the QC sample measurement.
11
After sampling stop→ Indicates [S.STOP]
ո Analyzer status monitor
After QC sample measurement completed→
12
Indicates [END]

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V.1.00
3.2.15 QC sample result confirmation

QC sample results are shown in next screens.
¾ Current QC screen : Latest QC measurement result list is shown.
¾ QC History screen : QC measurement result graph and list are shown for each Items.
When QC result is out of range or error occurred, confirm the reagent and QC sample.
Rerun or recalibration is required if necessary.
1. Current QC screen
¾ Latest QC measurement result is shown. QC result is reflected to the QC History.

¾ Rerun order of QC sample is possible in this screen.

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QC
screen-Current
QC screen

¾ Confirmation of QC result in “Current QC screen” follows
the procedure 1to7steps
¾ Rerun order of QC sample follows the procedure 8– 9 steps.
1 ᬅ QC Click “QC” button.

3 ᬆ Current QC Click “Current QC” button.
4 (PC screen) Current QC screen is shown.
5 ᬇ Control name: ▼ Select QC sample name.
Confirmation of QC result
մ Item Item name
յ Result Result value
ն Min, Max Result value which is within ±2SD.
6
¾ When result is out of s2SD, back color turns to
red.

Confirm no error within run.
ᬋ (Error flag)C 㹼AB
¾ When error occurred, related box turns to red.
3-24

¾ Please refer to Chapter 6 for details.
7 ո (Approve) The Approved result is reflected to QC History.

¾ Rerun order procedure of QC sample
Step Button & screen Operation & Display
¾ When the QC result is out of range or error occurred, perform the reagent and QC
sample check include expire date. Rerun or Recalibration is required if necessary.
Select the Item for rerun order.

8 չ Rerun
¾ The ordered Item turns to blue.
QC sample order and rerun order are registered.
¾ Rerun measurement of QC sample is same
9 պ Save procedure as patient sample.
Please refer to Chapter 3, 3,2,14 Patient sample
setting and measurement.

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V.1.00
2. QC History screen

¾ QC results are shown by graph or list.
Two QC sample results are able to display for one Item.

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շ շ

QC screen- QC History screen (Graph)

QC History screen (List)

2 (PC screen)㸧 QC screen is shown.
3 ղ QC History Click “QC History” button.
4 (PC screen) QC History screen is shown.
5 ճ Item name: ▼ Select Item name.
6 մ Control name: ▼ Select QC sample name.
3-26

7 յ Lot No.: ▼ Select QC sample Lot number.
8 ն Run date: ▼ Select date.
9 շ In box Display of the QC history graph or list.

Display of the statistical results for each
10 ո In box
sample.
11 չ Graph or List Select the graph or list.
¾ If the QC result is unstable which suspected systematic error or random error, the
analyzer needs to movement check and total maintenance include reagents and
sample.
¾ When the graph display, Westgard check mark is attached at upper part. Please
refer to Chapter 4, 4.5.4 QC History screen for details.

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V.1.00
3.2.16 Patient sample order entry

The order entry of patient sample in “Order “ screen.
When position mode is selected, order entry of patient sample in “Order” screen follows the
procedure steps.
¾ When barcode mode is selected, please refer to Chapter4, 4.2 Order screen.
(Patient sample order)

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Order screen
1 ձ Order Click “Order” button.

2 㸫 (PC screen) Order screen is shown.
Select measurement and sample information.
Tray No.: ▼ Select sample tray. (Essential)
ղ Select sample position number. (Essential)
Pos.: ▼
¾ Select by ‫ ۆ‬or ‫ ڼ‬buttons.
㸡of Asp: ▼ Select repetition number. (Essential)
Specimen: ▼ Select specimen. (Essential)
Patient ID Input patient ID
Name
3 Gender: ▼
(Patient ID input is necessary.)
Date of birth
ճ Age
Draw date: ▼ Select blood correcting date.
Draw time: ▼ Select blood correcting time.
Doctor㸸 ▼
(Patient ID input is necessary.)
Section㸸 ▼
L/H/I Select serum information.
Comment Input comment.
3-28

Click “Item select” button.

Item selection
4 մ ¾ When sample dilution is required, select
Dilution selection
dilution button and dilution ratio.
Select Item name.
¾ Back color of selected Item turns to blue.
5 յ 㸦Item name㸧
¾ When sample dilution selected, display the
dilution ratio under the Item name.
ն Order Displayed order entry screen is registered.
¾ Next order screen is shown automatically after
6 clicking of order entry button.
¾ When you continue the patient order, follow the
procedure 3 - 6 steps.
Confirmation of patient sample order entry
շ Sample state㸸 ¾ Display the “Order”.
7
ո ‫ۆ‬ ‫ڼ‬ ¾ All the order entry by clicking ‫ۆ‬ or ‫ڼ‬
button.
¾ Please refer to Chapter 4, 4.2 “Order screen” for profile order and group order.

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V.1.00
3.2.17 Patient sample setting and measurement

¾ Patient sample order confirmation in “Order” screen before sample setting on the tray
follows the procedure 1-4 steps.
¾ Sample setting on the tray and measurement start follow the procedure 5-13 steps.

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Order screen

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Main screen – Patient sample tray selection
1 ձ Order Click “Order” button.

2 (PC screen)㸧 Order screen is shown.
ղ Sample state㸸 Select “Order” status screen.

3
ճ ‫ۆ‬ ‫ڼ‬ Select screen by clicking ‫ ۆ‬or ‫ ڼ‬button.

3-30

Tray: ▼ Confirmation of patient sample order (Position)

մ
4 Position : ¾ Confirm the tray number and measurement
position.
5 յ յ Main Click “Main” button.

7 ն Tray Icon Select “Patient tray (Gray) Icon”.
Select tray number which checked in step 4 by
8 շ Tray Icon
Confirmation of order status on the tray.
¾ Back color of ordered position turns to blue.
9 ―
When the analyzer is running 㸻Green
Measurement completed㸻Orange
Set the patient sample which confirmed in step 4 on
10 ―
the sample tray.
11 ո Start Starts the measurement.
12
After sampling stop→ Indicates [S.STOP]
չ Analyzer status monitor
After patient sample measurement completed→
13
Indicates [END]
Note:
¾ Please be careful when dilution ratio is set 0.5, the sample is used two times volume.
¾ For ISE Items
1) When measuring the urine sample, need to make six times dilution sample by
exclusive dilution solution manually. The analyzer can’t make a urine dilution
sample automatically.
2) When using the plasma sample, blood collection tube of Heparin Lithium is
recommended for anticoagulant.

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V.1.00
3.2.18 Patient result confirmation

Patient sample results are shown in next 4 screens.
¾ Result screen 㸸Patient results are shown for each sample.
¾ Result Log screen 㸸Result list is shown.
¾ Patient Result screen 㸸Results of measurement day are shown for each sample.
¾ Data List screen 㸸Display of results, patient history and print out of patient
report. When using the data list (Patient report), patient
ID input in order screen is necessary.
1. Result screen

¾ Display of each patient result.
¾ Please refer to Chapter 4, 4.3 Result screen.

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մ

Ћճ

Result
screen

1 ձ Result Click “Result” button.

2 (PC screen)㸧 Result screen is shown.

Select tray number and position number.
3 ᬆ Tray_▼ Position ▼
Select the screen by clicking ‫ ۆ‬or ‫ ڼ‬button.
ᬇ ‫ۆ‬ ‫ڼ‬
Confirmation of patient result
Item
Item name.
Result
Result value.
4 ᬈ RC
Reaction monitor screen displays for selected Item.
‫ڧ‬C㹼D
No error within run.
¾ When error occurred, related box turns to red.
¾ Please refer to Chapter 6 .

3-32

2. Result Log screen

¾ Display of Result Log list (Within last 3 months).
¾ Please refer to Chapter 4, 4.1 Main screen 1.Result log screen.
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ն

Result Log screen
1 ձ Icon Click Icon.
2 (PC screen) Result Log screen is shown.

3 ղ From ▼ to ▼ Select the date.
4 ճ Specimen: ▼ Select “Specimen”.
5 մ Item When you display by Item, check the box ࣞ of Item.
6 յ Search Click “Search” button.
㸦Result display㸧 Confirmation of result

Item Item name.
7 ն Result Result value.
Error No error within run.
࣭࣭࣭ ¾ When error occurred, the error code is shown.
¾ Please refer to Chapter 6 .

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V.1.00
3. Patient Result screen

¾ Results of measurement day display by each sample order.
¾ Please refer to Chapter 4, 4.1 Main screen14. Result screen.

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ճ

Main screen –Patient Result screen
1 ᬅ ձ Main Click “Main” button.

3 ᬆ Patient result Click “Patient result” button.
(PC screen) Patient result screen is shown.
㸦Result display㸧 Confirmation of the measurement result

ճ Item Item name.
4 Result Result value.
Error No error within run.
࣭࣭࣭ ¾ When error occurred, “*”(asterisk) is shown in
related column.

3-34

4. Data List screen

¾ When using the Data List (Patient report), the patient ID input in order screen is
necessary.
¾ Display of Results, Patient History and print out the Single Report.
¾ Please refer to Chapter 4, 4.3.1 Data List screen.

Data list screen - Result screen

Data list screen - Patient History screen

Data list screen – Printing of Single Report
3-35

V.1.00
3.2.19 Inspection and maintenance at the end of operation

¾ Please perform the following check and maintenance at the end of operation.

1. Caution
¾ Please read and secure the ͆Preface͇ in operation manual for ͆Safety
caution- Caution in operation͇.
When you do the maintenance operation, wear protective globes, mask and
glasses to avoid the infection.

2. Inspection and maintenance

¾ Please refer to Chapter 5 Maintenance.
Step Operation
Cleaning of cabinet and reaction cell cover.

1 ¾ Remove the sample on the sample tray.
¾ Wipe the spilled sample and reagent.
2 Cleaning of sample and reagent probes.
Empty the drainage reservoir.

3
¾ When you discard the waste, follow the instruction of related law.
¾ When analyzer is attached the ISE unit, add the following inspections and
maintenance.
4 Cleaning of ISE sample pot.
5 Perform the ISE Wash.
Empty the ISE drainage tank.

6
¾ When you discard the ISE waste, follow the instruction of related law.
Check the residual Calibrator 1.

7
¾ Replace the Calibrator 1 if necessary.

3-36

3.2.20 Shutdown
¾ Please refer to Chapter 4, 4.10 “Exit” screen when perform the shutdown for automatic
start up and after automatic maintenance.

ЌЌ Ќ
յ(Pop up screen)
ղճ ձ
Exit screen

նЍ

Ћմ
Main
screen

Step Button&Screen
Operation & Display
Click system power switch Icon.
1 ᬅ Icon ¾ Analyzer system power turns off.
The Icon is inactive when running the analyzer.
Analyzer status
2 ᬆ ¾ Confirmation of the indication [OFF LINE].
monitor
Temperature
3 ᬇ ¾ Confirmation of the indication [---].
control monitor
4 մ Exit Click “Exit” button.
5 յ (PC screen) Popup dialog “Exit” screen is shown.
6 ն End Select “End”.
7 ― Turn off the system program.
8 ― Turn off the PC power switch.

Turn off the analyzer main power switch.
9 ―
¾ The main power switch is left rear side.
3-37

Chapter 4
Explanation of each screen and operating condition

4.1 Main screen ...................................................................................................................... 4

4.1.1 The content of Main screen .......................................................................................... 4
1. Result Log screen ......................................................................................................... 7
2. Error list screen ........................................................................................................... 9
3. Help screen ................................................................................................................. 10
4. Lamp screen ............................................................................................................... 11
5. Tank error screen ....................................................................................................... 12
6. Analyzer status monitor, temperature control status monitor and System power
switch................................................................................................................................. 13
7. Operation control button. (Start, QC start, Ready, Stop) .......................................... 14
8. Sample tray monitor screen ....................................................................................... 15
9. STAT button ............................................................................................................... 16
10. Add sample ................................................................................................................. 17
11. Reagent tray monitor screen ...................................................................................... 18
12. Order information screen ........................................................................................... 19
13. Reaction information screen ...................................................................................... 20
14. Reagent information screen ....................................................................................... 21
15. Patient result screen .................................................................................................. 22
4.2 Order (Patient sample order entry) screen.................................................................... 23
4.2.1 The contents of Order screen ..................................................................................... 23
1. Test condition input and display ................................................................................ 24
2. Sample information (Patient information) input and display ................................... 26
3. Test item display and selection .................................................................................. 29
4. Profile list display and selection ................................................................................ 30
5. Order setting (Group order) button ........................................................................... 31
6. Work list screen .......................................................................................................... 32
7. Order screen switching button ................................................................................... 34
4.3 Result screen ................................................................................................................ 35
4.3.1 Result screen display contents ................................................................................... 35
1. Test results condition display..................................................................................... 36
2. Result and sample information (patient information) display .................................. 37
3. Test results display, Rerun order, Reaction monitor screen display button .............. 39
4. Data list ...................................................................................................................... 40
5. Test result screen switching button ........................................................................... 48
4.4 Calibration screen .......................................................................................................... 49
4.4.1 The contens of CAL screen ......................................................................................... 49
6. CAL screen -Item order, results ................................................................................. 50
7. CAL screen ― Graph screen ....................................................................................... 51
8. Calibration order ...................................................................................................... 52
9. Calib. settings screen ................................................................................................. 53
10. Cal Data screen .......................................................................................................... 54
11. ISE CAL screen - Order and result display............................................................. 56
4-1

V1.00
12. ISE graph screen ........................................................................................................57

13. Calibration profile, Order all and cancel button ........................................................58
4.5 QC screen........................................................................................................................59
4.5.1 QC screen contents .....................................................................................................59
4.5.2 Order QC screen .........................................................................................................60
4.5.3 Current QC screen ......................................................................................................62
4.5.4 QC History screen .......................................................................................................64
4.5.5 Control settings screen㸦QC sample setting screen㸧 ...............................................67
4.6 Reagent screen ...............................................................................................................69
4.6.1 Reagent screen .........................................................................................................69
4.6.2 Bottle Info. screen㸦Reagent bottle information screen㸧.........................................70
4.6.3 Reagent settings screen㸦Reagent bottle setting screen㸧 ........................................72
4.7 Item screen .....................................................................................................................74
4.7.1 Item screen contents ...................................................................................................74
4.7.2 Optical screen .............................................................................................................75
Condition setting of concentration result transforms to qualitative result. .................78
4.7.3 ISE screen ...................................................................................................................80
4.7.4 HbA1c screen ..............................................................................................................82
1. HbA1c screen㸦For Latex reagent Item No.101,102) ................................................82
2. HbA1c screen㸦For enzymatic reagent Item No.106) ................................................86
4.7.5 Calculation Screen ......................................................................................................90
4.7.6 Other㸦Serun information, detergent, diluent, lysing solution screen㸧 ..................92
4.8 Maintenance ...................................................................................................................95
4.8.1 Maint.screen ...............................................................................................................95
4.8.2 ISE CRS screen (ISE correlation measurenment) .....................................................98
4.8.3 Auto gain screen information ...................................................................................100
4.9 System screen ...............................................................................................................101
4.9.1 System buttons .........................................................................................................101
4.9.2 Maintenance List screen...........................................................................................103
4.9.3 Reaction monitoy screen ...........................................................................................105
4.9.4 Profile screen ............................................................................................................107
4.9.5 Cell Blank screen ......................................................................................................109
4.9.6 System Parameter screen ......................................................................................... 111
4.9.7 Samlpe confirmation screen ..................................................................................... 115
4.9.8 Wash Settings screen㸦Carry over avoidance㸧 ...................................................... 117
4.9.9 Reagent Barcode screen............................................................................................ 119
4.9.10 Manual Operation screen .........................................................................................120
1. STF............................................................................................................................122
2. STM...........................................................................................................................123
3. SP ..............................................................................................................................125
4. RGT ...........................................................................................................................126
5. RTM ..........................................................................................................................127
6. RP..............................................................................................................................129
7. RCT ...........................................................................................................................130
8. MU ............................................................................................................................131
9. MP .............................................................................................................................132
10. CWS ..........................................................................................................................133
11. CWP ..........................................................................................................................134
12. PWP ..........................................................................................................................135
4-2

13. DP ............................................................................................................................. 136

14. Alarm ........................................................................................................................ 137
15. Level ......................................................................................................................... 138
16. ISE ............................................................................................................................ 139
4.9.11 Temperature screen.................................................................................................. 141
4.9.12 Initialization screen ................................................................................................. 143
4.9.13 Authority Settings screen ........................................................................................ 144
4.9.14 Version screen .......................................................................................................... 145
4.9.15 Log in screen ............................................................................................................ 146
4.10 Exit screen ................................................................................................................... 147
4.10.1 Exit button ............................................................................................................... 147
4.10.2 Setup schedule start screen ..................................................................................... 148
4-3

V1.00
4.1 Main screen
The following informations are shown in Main screen.

4.1.1 The content of Main screen
ձ ղ ճ մ յ ն շ ո
չ Ў Ў Ў Ў Ў Ў Ў Ў

Ў

վЍ

ջ

պ
տ
Ў

ս

Ќ
ռ Main screen

ձ 㸸Result log screen is open.
ղ 㸸Error list screen is open.
ճ 㸸Help screen is open.
մ 㸸When lamp is ON, turns to yellow.
Display of remain time of lamp life.
յ 㸸When tank error occurred, turns to red.
Displays of the analyzer status monitor.

ն>Analyzer status monitor@ 㸸Indicates the analyzer status.
շ>Temperature control status monitor@ 㸸Indicates the reaction tray
temperature control status.
ո 㸸System power switch.
չCondition setting and operation button.

Main 㸸Main screen
Order 㸸Patient sample order entry screen
Result 㸸Test result screen
CAL 㸸Calibration menu screen
QC 㸸QC menu screen
Reagent 㸸Reagent information screen
Item 㸸Item parameter screen
Maint. 㸸Maintenance menu screen
4-4

System 㸸System menu screen

Exit 㸸Ending operation screen
պOperation control button

Start 㸸Test starting button, both for patient sample and
Calibration sample
QC Start 㸸Test starting button, for QC sample in QC screen.
Ready 㸸Analyzer initializing
E.Stop 㸸Emergency stop
ջSample tray character display

Expanded tray is shown at the center for each tray selection.
The number (1, Q1, C1) at the center of display is tray number.
¾ QC tray can be selected “ON” in System parameter.
Color Tray kind
Gray Patient sample tray
Yellow Calibration sample tray
Pink QC sample tray

When patient sample tray is set, the following information are shown.
STAT 㸸Select when set the STAT sample.
STAT sample setting position screen is shown, when
analyzer is under operation.
Add sample 㸸Select when set the additional sample.
Analyzer stops sampling, for additional sample testing.
ռTesting status monitor (Information table)

: Each sample position on sample tray is colored,
depending on the analysis stage.
State Color Analysis stage
Empty White No sample order
Ordered Blue Waiting
Running Green Test is running.

Completed Orange Test has finished

Reordering Gray Rerun is ordered

Error Red Test has failed

սReagent tray monitor
Reagent bottle residual volume range is shown by color.
The number at the display is bottle position number.
Color Reagent residual status
Gray No reagent bottle setting
Blue Above alarm level
Red Below test stop level
Yellow Below alarm level
Effective date or effective date
Green
after open is expired.
4-5

V1.00
վTest status information request button

Screen changes by clicking each buttons.
Order info. 㸸Order entry status
Reaction info. 㸸Test status
Reagent info. 㸸Reagent information
Patient Result 㸸The test results of each sample.
տDetailed information screen display

When you choose one of the buttons of վ, detailed information are shown.
4-6

1. Result Log screen

¾ Result Log Icon displays at the upper part in operation screen. Result log screen
is able to open when analyzer is under operation.
¾ Display the result log list of running date. The list is shown by selected date,
specimen and Item. The result log designated range in the list export to CSV file
or external printer.

ձ Clicking button, result log screen opens.
ղ ձ

Ў

ճ Ћն
մЍ
չЍ

պЍ
յ

շ

ո
Ў

Result log screen

ղ From ‫ۂ‬to ‫ۂ‬㸸Select the starting day and final day of interest.

ճ Sample Type 㸸Select sample type of interest.
‫ڧ‬ALL ‫ڧ‬Patient ‫ڧ‬Calibration ‫ڧ‬Control

մ Item 㸸Open յ Item list screen.
յ Item selection list 㸸Result is able display by Item.
To select individual test item,

‫ڧ‬Item name input a check mark into desired
check box.
Select all items, shown in the
All Item Select
table.
All Item Clear To clear all registered items.
To register the contents of the
OK
table.
Cancel Item selection screen is closed.
4-7

V1.00
նSearch 㸸Click search button, test results are shown in շarea.

շDisplay of the result and information.

Contents

Date /Time Tested date and time

RC No. Reaction monitor number
Pos. Tray number - Position number
PatientID/ Control Name Patient ID/ QC samle name
Displays ID by selected mode.
Sample ID ¾ Position mode ; Sample ID
¾ Barcode mode ; Sample barcode ID
Item Item name
Abs. Optical absorbance
Result Test result
The result of qualitative judgement.
Qualitative ¾ Registration of qualitative judgement
condition is necessary in Item parameter.
Error code
Error
¾ Refer to Chapter 6, Alarm function.
Dil. Dilution ratio

ո Add line 㸸“Add line” box is used for test result export to CSV file
or external printer.
Export and Printout range setting.
Input Log number (Left end number)
Select the lines (Turns to blue), and click Add line
button.
(In case of mutiple line selection)
Insert conma between the lines.
(In case of continues range selection)Insert hyphn
between the numbers.

չ CSV 㸸The result log designated in ոAdd line is export to
CSV file.

պ Print (external printer)
㸸The result log designated in ոAdd line are printed out
by external printer.

4-8

2. Error list screen

¾ Error list Icon displays at the upper part in operation screen. Error list screen is
able to open when analyzer is under operation.
¾ Display the error list of the day. The list is able to show by selected date.

ᬅ Clicking button, Error list screen opens.

ղ ճ
Ў Ў
ձ Ћյ

մ

Error list screen

ᬆ From ‫ۂ‬to ‫ۂ‬㸸Select the starting day and final day of interest.
ᬇ Search 㸸Click Search button, Error list is shown in մ area.
ᬈ Display of the error code and information.
Contents
Date /Time Date and time when error occurred.
Error level (1-3) is shown.
[1]: Emereny stop error or screen error
Level (When error occurred, screen changes automatically)
[2]: Sampling stop (Tank error, clot error)
[3]: Warning error
Error No Error number
Sample Sample number
Item Item name
Message Content of the error
ᬉ ‫ڧ‬Detail information : Check the box ‫ڧ‬for error information display.

Contents
Cycle, Tact1࣭2,
Status, Log No., Please tell the number when inquiring about the error.
Time
4-9

V1.00
3. Help screen

¾ Help screen Icon displays at the upper part in operation screen. Help screen is
able to open when analyzer is under operation.
ᬅ Clicking button, Help screen opens.
4-10

4. Lamp screen

¾ Lamp Icon displays at upper part in operation screen. Lamp screen is able to
open when analyzer is under operation.
ᬅ Clicking Lamp button.

ձ

Main screen

ղ

Lamp screen

ᬆ Lamp screen opens.
Contents
Display of remain time of lamp life.
Time Left for Lamp
(Maximun 1200 hours)
Select when changing the lamp
Exchange
Reset the remaining time.
Exit Close the lamp screen.
4-11

V1.00
5. Tank error screen
¾ Tank Icon displays at the upper part in operation screen. Tank creen is able to
open when analyzer is undr operation.
ᬅ When tank error occurred, tank Icon turns to red. (supply water, drainage,
detergent and separate drainage tanks)
¾ When tank error solved, the Icon turns to blue.

ձ

Main screen
4-12

6. Analyzer status monitor, temperature control status monitor

and System power switch

¾ Analyzer status monitor, temperature control status monitor and system power
switch button display at the upper part in operation screen.
ձ ղ ճ
Ў Ў Ў

Main screen

ձ [Analyzer status monitor]㸸The analyzer status is shown.
Notation Analyzer status
OFF LINE PC is not connected with analyzer.
IDLE PC is connected with analyzer.
Analyzer is ready to start testing.
READY
All the units move to start position)
INIT Under Initialization operation.
RUN Analyzer is running tests.
S.STOP Sampling stop
END Analyzer has finished all tests.
CLOT Sampling nozzle is clogged. (Keep clog
BARCODE Reagent barcode reading operation is going.
GAIN Auto-gain action is going.
MAINTE Maintenance action is going.
CRS CRS test is going.
ᬆ [Temperature control status monitor]㸸The reaction tray temperature control
status is shown.
Notation Status
--- No temperature control
After the temperature control starting, the reaction tray
WARM UP
temperature does not reach 37Υ s0.1Υ
Under the temperature control, the reaction tray
OK
temperature is 37Υ s0.1Υ
Under the temperature control, the reaction tray
NG
temperature is out of 37Υs0.1Υ after [OK] status.
ᬇ Icon The Icon is system power switch.

Clicking this button, system power switch is turned ON or
OFF.
4-13

V1.00
7. Operation control button. (Start, QC start, Ready, Stop)
¾ Operation control buttons (Start, QC start, Ready, Stop) display at the right
lower part in operation screen.
¾ The button changes to inactive depending on the analyzer status. The color
turns to gray.

ձ’Ѝ

ձЍ

ղЍ

ճЍ

Main screen

ձ Start 㸸Test starts.

ձ’ QCStart 㸸When analyzer is QC testing mode, Start button is replaced
by this button. QC sample tests start.
ղ Ready 㸸Analyzer initialization starts.

ճ E.Stop 㸸All the analysis operation stops.

4-14

8. Sample tray monitor screen
¾ Sample order status is shown by tray Icon in main screen.

ձЍ Ћղ Ћճ

Ћն

Ћշ

մЍ

յЍ

Main screen

¾ The selected tray is shown on a central area. The order status displays by the
color.
¾ The number in Icon shows tray number. The tray number is changed by
keys.
¾ մQC tray can be selected “ON” in System parameter.
ձ Main button : Main screen is shown.

ղ㹼մ Tray Icons
Usable tray
Color Analysis
number
ղ Patient sample tray Gray Patient sample measurement 1 㹼 50
ճ Calibration tray Yellow Calibration measurement C1 㹼 C6
մ QC sample tray Pink QC sample measurement Q1 㹼 Q3
յ The order entry status

Color Order status
White Empty No sample order
Blue Ordered Waiting
Green Running Test is running.
Orange Completed Test has finished
Gray Reordering Rerun is ordered
Red Error Test has failed
¾ When patient tray is set, the following buttons are shown.

ն Stat : Select for Stat sample.
࣭The Stat sample position screen is shown under operation.
շ Add Sample 㸸Select for additional sample under operation.
࣭The sampling stops after clicking the button.
4-15

V1.00
9. STAT button

¾ Clicking “STAT” button, STAT sample measurement is possible.
¾ STAT button displays when patient tray is selected in main screen.
¾ STAT button is able to use when analyzer is under operation.
¾ STAT sample is performed cut in between the measuring sample.

ձЍ Ћղ

Ћճ
մ

Main screen- STAT sample position setting screen

ձ Main button : Main screen is shown.
ղ Patient tray Icon : Patient tray displays in center part.
ճ Stat button : Select when stat sample order.

մPop-up screen for STAT sample test position designation
screen appears.
Pop-up screen
մ Stat sample position designation screen : Set the stat sample position.
Start Sample No. Input stat sample start number.

End Sample No. Input stat sample end number.
OK Stat sample measurement starts.
Cancel Close stat sample position designation screen.

4-16

10. Add sample

¾ Clicking “Add sample” button under operation (sampling), the sampling stops.
¾ Add button displays when patient tray is selected in main screen.

ձЍ
Ћղ մ

Ћճ յ

ն

Main screen
ᬅ Main button : Main screen is shown.

ᬆ Patient tray Icon : Patient tray displays in center area.
ճAdd sample button 㸸Select when required additional sample test

մPop-up screen appears.

Pop-up screen
մDo you add sample? 㸸Clicking of OK when add the sample.
¾ յPop-up screen appears.
㸸Clicking of Cancel when cancel the sample addition.
¾ Close the Pop-up screen, and analyzer continues
operation.
յPlease wait a minute? 㸸Sampling stops.
նPress OK button after setting samples.

¾ Set add sample on the sample tray.
OK : Clicking OK, and restart the sampling.

4-17

V1.00
11. Reagent tray monitor screen
¾ Reagnet tray information displays in main screen.

ձЍ

ղ

Main screen

ᬅ Main button : Main screen is shown.

ᬆ Reagent tray Icon : Reagent residual volume is shown by color.
¾ The number in Icon is shown bottle position
number.

Color and status
Color Reagent residual status
Gray No reagent bottle setting
Blue Above alarm level
Effective date or effective date after
Green
open is expired.
¾ Alarm level and test stop level are set in syste screen.
Refer to Chapter 4, 4.9.6 System setting.

4-18

12. Order information screen

¾ Order information list displays.
¾ Clicking “Order info.” button in main screen, displays “Order info.” screen.

ձЍ ղЍ

э

Select order entry status line in order info. screen.
ճ

Result screen

ᬅ Main button 㸸Main screen is shown.
ᬆ Order info. button 㸸Order entry status is shown.
Contents
Tray Sample Tray number
Sample No. Sample position number
Sample ID Displays ID by selected mode.
࣭Position mode ; Sample ID
࣭Barcode mode ; Sample barcode ID
Receipt time Receipt time
Schedule time Forecast of test ending
End time Time of test has finished.
ᬇ Select order entry status line and double click it, screen changes to result screen,
corresponding to the test item.
4-19

V1.00
13. Reaction information screen
¾ Real reaction information displays.

¾ Clicking “Reaction info.” button in main screen, displays “Reaction info.” screen.

ձЍ ղЍ

ᐃ๓̿5HDFWLRQLQIR⏬㠃

Under operation ― Reaction info.screen
ᬇ Main button : Main screen is shown.

ᬈ Reaction info. : Real time display of test status
Back color display
Back color Contents
Blue Single reagent or ISE Item (Other Item)
Pink Double reagent Item
Characters display
Contents
Cycle(1~60) Light intensity measurement point number
R1 R1 reagent dispensing point
S, M Sample dispensing and mixing point
(Cycle 9)M Mixing point (R1 + Sample)
R2 R2 reagent dispensing point
(Cycle 32, 33) M Mixing point (R1+Sample + R2)
Number (0-9) Waiting time till test complete.
Sample position, barcode number or patient ID
Sample ID ¾ Set Run monitor dsipaly in System Parameter
screen.
Item Test Item

4-20

14. Reagent information screen
¾ Reagent information list (Item name, residual reagent) is shown.

¾ Clicking “Reagent info.” button in main screen, displays “Reagent info.” screen.
ղ
Ў
ձЍ

Main screen

ᬆ Reagent info. button 㸸Residual reagent test number display.
Back color changes depending on reagent residual
volume level.
Back color display㸸
Back color Reagent residual volume
White Enough reagent volume
Effective date or effective date after open
Green
is expired.
¾ Alarm level and test stop level are set in system screen.
Please refer Chapter 4, 4.9.6 System setting.
Characters display:
Contents
Pos Reagent tary and bottle position
Item Item name
R1 R1 reagent residual test number
R2 R2 reagent residual test number

4-21

V1.00
15. Patient result screen
¾ Results of measurement day display by each sample order.

¾ Clicking Patient result button in main screen, displays patient result
screen.
Ўղ
ձЍ

Ћճ
Main screen ̿ Pstient Result screen

ᬆ Patient Result button 㸸Patient results of the day are shown by each sample
order.
Contents
Sample㸸- Sample tray number – sample position number
Type㸸 Sample kind
Date/Time Date and time (Format depends on PC)
Displays ID by selected mode.
Sample ID ࣭Position mode ; Sample ID
࣭Barcode mode ; Sample barcode ID
Patient ID Patient ID (Only for patient sample)
Patient name (for patient sample)
Name
QC sample name (for QC sample measurement)
Item Name Item name
Result Test results
Dil Dilution ratio ͤFor no dilution sample, blank.
NR Error flag (Low,High,PL,PH)
C,E,L,P㹼
When error occurred, “*”(asterisk) is shown in related column.
R1,R2,D
----RC---- Reaction monitor number
¾ Please refer to Chapter 6 Alarm function.
ᬇ Print (external printer)㸸Test results are printed out by external printer.
¾ Printout range is designated by drag.

4-22

4.2 Order (Patient sample order entry) screen
This screen is used for order entry of patient samples.

¾ There are two kinds of order entry screen, one is used for position mode and the
other is used for barcode * mode. The sample mode can be selected in System screen.
Default mode is Position mode.
¾ Order entry operation is possible during test operation, but order modification or
test cancellation for the sample, which is under test stage, is impossible.
¾ Order entry status is shown in Work list of this screen.

4.2.1 The contents of Order screen

ղЎ

ձЍ

յ

ճ մ

Ћն

ոЌ շЌ
Order screen

ᬅ Order button 㸸Order screen is shown.

The following items are used in order screen.
ᬆ Test condition ( tray, position number) input and display
ᬇ Sample information (Patient information) input and display
ᬈ Test item display and selection
ᬉ Profile list display and selection
ᬊ Work list and order status display button
ᬋ Order entry button
¾ “Goup order” button is cannot used when sample mode is barcode mode.
ᬌ Order entry page switching button.
4-23

V1.00
1. Test condition input and display

ղЎ

ձЍ

ճЍ

Order screen

ᬅ Order button : Order screen is shown.
ᬆ Test conditions (tray, position number) input and display.
Input and display of test conditions are different depending on the sample mode.
The sample mode can be selected in System screen. Default mode is Position
mode.
¾ Position mode Order screen

Display contents, input condition, contents of the selection
Select a number Input is
Tray Sample tray number selection
1– 50 essential.
Input a position Input is
Pos. Sample position number input
number 1㹼30 essential.
The contents of display are different by the display contents of
[Sample state].
¾ In case of [Clear], Round name, selected in Reagent screen, is
Round
shown.
¾ Other than [Clear], the [Round name], at the time of order
entry, is sown.
Select Item This function is selected for ordinary order entry.
Select Dil. This function is selected when order entry with sample dilution.
Test date displays
¾ Former date selection is
Default date is Input is
Test date possible.
today. essential.
¾ Confirmation of order entry
for past date is possible.
4-24

¾ Barcode mode order screen

Display of sample barcode contents, and input or read by barcode reader
automatically.
Tray Fixed as tray number 1. Cannot be changed.
Pos. No input is acceptable.
Display contents are different depending on the display contents of
[Sample state].
¾ In case of [Clear], Round name, selected in Reagent screen, is
Round
shown.
¾ In case of the other than [Clear], Round name, selected in order
entry is shown.
Select Item This function is selected for ordinary order entry.
Select Dil. This function is selected when order entry with sample dilution.
Test date displays
¾ Former date selection is
Default date is Input is
Test date possible.
today. essential.
¾ Confirmation of order entry
for past date is possible.
ᬇ Dilution rate setting

¾ Dil Rate displays after clicking the Select Dil button.
¾ This section is common for Position mode and Barcode mode.

Select one out of 0.5 6, 10, 20,
Dil. Select dilution ratio.
30, 40, 50, 60, 70, 80, 90, 100.
Note:
¾ Please be careful when dilution ratio is set 0.5, the sample is used two times
volume.

4-25

V1.00
2. Sample information (Patient information) input and display

ձЍ

ղ

Order screen

ᬆ Sample information (Patient information) input and display.
Input and display of test conditions are different depending on the sample mode.
mode.
¾ Position mode Order screen

Display contents, input condition
Barcode▼ No input is possible.
Select sampling repetition
# of Asp▼ Select 1 – 10 Default is 1
number.
Serum
Urine
Plasma
CSF
Default is
Specimen▼ Sample kind selection Dialysis
Serum
Other
HbA1c(Wholeblood)
HbA1c(Primary tube)
HbA1c(Hemolyzed)
Patient ID input Less than
Patient ID ¾ When using of result screen data list (patient 20 letters
report), input is necessary.
¾ To input Name – Age, Patient ID input is necessary.
Name Input patient name. Less than 30 characters
Select one out of Male, Female and
Gender▼ Select gender.
unknown.
4-26


Input the date of birth, by input a check mark into a box or select
Date of birth
the date out of the calendar by clicking ࣞ mark.
Age Displayed automatically.
Input the date by input a check mark into a box or
Default is
Draw date select the date out of the calendar by clicking ࣞ
today.
mark.
Input draw time, or select draw time.
Draw time
¾ Draw date input is necessary before time input
¾ Patient ID input is necessary before Doctor – Section input.
Select Doctor name
Doctor ▼
¾ Doctor name registration is done in Tools screen.
Select Section
Section ▼
¾ Section registration is done in Tools screen.
Lipemic/
Serum information selection.
Hemolysis/
¾ Select one out of 2-, -, +-, 2+, 3+, 4+.
Icteric
Comment Input comment Less than 30 characters
Clear (No order entry)
Order
Sample state Sample state displays Run
Complete
Error (Error has detected)
Order (First test)
Order state Display of order entry status Re-run order
Auto-rerun order
¾ Barcode mode order screen

¾ Input or read sample barcode information contents and displays it
Input or display a sample barcode character Less than 20
Barcode ▼
string. characters
Select sampling repetition
# of Asp ▼ Select 1 – 10 Default is 1
number.
Select sample kind or displays barcode
information.
Serum
Urine
Plasma
Default is
Specimen ▼ CSF
Serum
Dialysis
Other
HbA1c(Wholeblood)
HbA1c(Primary tube)
HbA1c(Hemolyzed)
4-27

V1.00

Patient ID input or displays of barcode
information. Less than 20
Patient ID
¾ When using of result screen data list letters
(patient report), input is necessary.
¾ To input Name – Age, Patient ID input is necessary.
Input patient name or display of
Name Less than 30 characters
barcode information..
Select gender or display of barcode Select one out of Male,
Gender▼
information. Female and unknown.
Input the date of birth, by input a check mark into a box or select
Date of birth
the date out of the calendar by clicking ࣞ mark.
Age Displayed automatically.
Input the date by input a check mark into a box or
Default is
Draw Date select the date out of the calendar by clicking ࣞ
today.
mark.
Input draw time, or select draw time.
Draw time
¾ Draw date input is necessary before time input
¾ Patient ID input is necessary before Doctor – Section input.
Doctor name registration
Doctor▼ Select Doctor name
is done in Tools screen.
Section registration is
Section▼ Select Section
done in Tools screen.
Lipemic/
Serum information selection.
Hemolysis/
¾ Select one out of 2-, -, +-, 2+, 3+, 4+.
Icteric
Comment Input comment Less than 30 characters
Order
Sample state Sample state displays Run
Complete
Order (First test)
Order state Display of order entry status Re-run order
Auto-rerun order

4-28

3. Test item display and selection
¾ During Reagent screen selection, registered reagent Items, ISE Items and
calculation Items are shown in Round. By specimen selection, only the Items,
suitable for the specimen, are shown.
¾ Order entry by Item selection.

ձЍ

ղ

Order screen
ձ Order button : Order screen is shown.

ղ Test item names are shown.
¾ Clicking Item name for order entry
Back color and status㸸

Back color Order entry status
White No order entry

Blue Order is accepted
Dark blue ( Item name) Test has finished

¾ When selected sample dilution, display dilution ratio under the Item name.

4-29

V1.00
4. Profile list display and selection
¾ Profile list displays.

Group order entry can be set by profile name selection.
¾ Profile setting or modification is done in System screen.
Please refer to Chapter 4, 4.9.4 Profile screen.

ձЍ

ղ

Order screen

ᬅ Order button 㸸Order screen is shown.
ᬆ Profile 㸸Profile name displays.
Select profile name, registered Items in profile are entry.
Contents
Select all All Items shown are selected and ordered.
Clear all Clear for all Items entry.
㸦Profile name㸧 Enter the all test Items set in the profile.
‫ڼ ۆ‬ Displays former or later profile name.
4-30

5. Order setting (Group order) button
¾ This button is used for order setting.

ձЍ
մ

ղ

ճЍ
Order screen
ձ Order button : Order screen is shown.

ղ Buttons
Contents
Clear If there is a order, cancel them.
Delete Delete the test order of displayed position number.
Order Register the contents of displayed position number.

ճ Group Order button : մ Group order designation screen is pop-up.
¾ Group order entry registration screen is shown.
Order entry of a set of test items can be applied for
multiple samples in one action.
¾ Under Barcode mode, cannot be used.
Pop-up screen
մ Group order screen
Contents
Display of starting sample number for group
order entry.
Start sample No. ¾ The sample number, which has been shown in
order entry screen, when group order button is
selected.
Select the final sample number of group order
End sample No.
entry.
OK Do group order entry.
Cancel Cancel the group order entry.
4-31

V1.00
6. Work list screen
¾ Clicking of work list button, work list screen is shown.

¾ This is used for order entry status confirmation.

ձЍ

ղ

Ў

ճ

Work list screen

ᬆ Work list button : Order entry status list is shown.
ᬇ Work list screen
Contents
Select one out of All, Patients,
Sample Select sample kind
Controls.
Select one out of All, Pending,
Sample status Select sample status.
Measured.
Select the date to be displayed. Former date selection is
Test Date
possible.
Sample tray number (left side) and sample position

Pos.
number (right side) are shown.
Sample ID Sample ID (Automatic numbering) or barcode ID is shown.
Patient ID Patient ID is shown.
Specimen Specimen display
Item number If test order is registered, “*” is shown in Item name
/ Item name column.
Total Total test number for each test items are shown.
4-32

մ Print (External printer) : Printout of displayed contents.
4-33

V1.00
7. Order screen switching button
¾ Order screen switching buttons are shown.

¾ Displays when position mode is selected. Under barcode mode, this screen is
ignored. Under barcode mode, select Barcode ▼, for screen switching.

ձЍ

ղ

Order screen-Position setting screen

ᬆ Order screen switching buttons and functions
Contents
Displays the first position of shown round.

Former Item
search button Displays the Order screen of one step smaller
position number from displayed screen.
Displays an Order screen of inputted position
Search button
number.
Displays Order screen of one step larger position
Later Item search number than displayed screen.
button Displays the Order screen of the largest position
number, among test order has already entered.

4-34

4.3 Result screen

¾ Test result of each sample is shown.
¾ Depending on the sample mode setting, (Position mode/Barcode mode) display
contents are different.
Sample mode setting can be changed in System screen. Default is Position mode.
¾ Rerun order is possible.
¾ Test result search and Patient report (Patient history) print out are possible using
Data list screen.

4.3.1 Result screen display contents

ղЎ

ձЍ

Ќ
ճ յ
մ

նЍ

Result screen
ᬅ Result button : Result screen is shown.
Result screen display contents are followings.

ᬆ Test result condition (tray, date) display and selection.
ᬇ Sample information (Patient information) displays.
ᬈ Test results (test Item, test result data, error content).
Rerun test Item registration.
Reaction monitor displays.
ᬉ Rerun order registration.
Data list screen displays
Result request.
ձ Test results screen display exchange button
¾ This button is not shown under sample barcode mode.

4-35

V1.00
1. Test results condition display
¾ Test result of the day is shown. Display order entry when the test incomplete.
¾ Former test results are also shown if date of interest is given.
ղЎ

ձЍ

Result screen
ձ Result button : Result screen is shown.
ղ Result screen and functions

Display contents, selection contents
Tray No. Sample tray number selection Select a number 1– 50
Pos. Sample position number input Input a position number 1㹼30
Round Round name display
Test date display
Test Date ¾ Former date selection is Default is today.
possible.

4-36

2. Result and sample information (patient information) display
¾ Display the information of order entry.

ձЍ

ղ

Result screen

ղ Sample information (Patient information) displays.

Contents࣭(Rerun condition input)
Barcode Displays barcode character string.
Repeat ‫ۂ‬ Display sampling repetition number. (1-10)
Serum
Urine
Plasma
CSF
Specimen Display sample kind Dialysis
Other
HbA1c(Wholeblood)
HbA1c(Primary tube)
HbA1c(Hemolyzed)
Patient ID Display patient ID
Name Display patient name.
Gender Display gender
Date of Birth Display date of birth
Age Display age
Drow date Display drow date
Drow time Display drow time
Doctor Display doctor
Section Display section
4-37

V1.00
Contents࣭(Rerun condition input)

L 㸸H 㸸 I Serum information (Lipemic, Hmolysis, Icteric) display
Comment Display comment
Order
Sample status Display sample state Run
Complete
Order (First test)
Ordering status Display order state Re-run order
Auto-rerun order

4-38

3. Test results display, Rerun order, Reaction monitor screen display

button
¾ Test results are shown. Display order entry when the test incomplete.
¾ Rerun order is possible by check the rerun box.
¾ Clicking RC button, displays reaction monitor screen.

ճ

ձЍ

մ

ղ

Result screen

ᬆ Result screen
Contents
Order the test.
¾ Select the box for test Item.
Order
¾ Blue color box means order has entered.
¾ Order is able to order within day.
Item Test Item name display
Dil. ‫ۂ‬ Dilution ratio display. Dilution ratio setting for rerun test is done.
Result Test result display. Rerun test result displays lower line.
If the test result is out of normal range, displays Low or High. If the
LH
test result is out of panic range, displays PL or PH.
㸩㸫 Qualitative judgment .
Reaction monitor display
RC Select RC button, reaction monitor screen displays.
¾ Please refer to Chapter 4, 4.9.3 Reaction monitor screen.
Unit Unit display
C~D The C-D is shown error flag. If error occurred, chenage the color to
red.
¾ As for check flag, refer to chapter 6 Alarm function.
ᬇ Order button : Rerun order for selected Item (which is shown as a blue
box in Rerun box).
ᬈ Request button : Select button when the result is not received.
Receive the result and display.
4-39

V1.00
4. Data list
¾ Displays Data list (Patient report) screen
Data list (Patient report) screen

Display, search, print setting, and print for test result of Data list (Patient
report) are done in this screen..
¾ To use Data list (Patient report), Patient ID input in Order screen is necessary.

ղ
ճ
ձЍ

Data list menu screen

ᬆ Data List button : Data list menu screen is popup.
Pop-up screen
ᬇ Buttons and functions
Contents
Result Test result list display, search, print
Patient History Test result list for each patient display, search and print.
Patient report printing contents (Profile) setting, search
Single report
and print.
Setting of display contents for Patient report printing
Header㸭Footer
header and footer.
Exit Close Data list screen

4-40

4-1. Data list – Result screen
¾ Test result of Data list (patient report) display, list, search and print.
¾ To use Data list (Patient report), Patient ID input in Order screen is necessary.

ճ ղ

ձЍ

screen
Result

մData list – Result screen

յ շ ո

Ў Ў Ў

նSearch screen
ᬅ Result button 㸸 Result screen is shown.

ᬆ Data List button 㸸Data list menus creen is popup.
Pop-up screen
ᬇ Data list menu screen
Result button 㸸Result screen is hown.
¾ Displays test result list, search and print screen.
Pop-up screen
ᬈ Result screen : նDisplay of search results.
Contents
Test Date ▼ Test date display and search
Patient name Patient name display
Tray Tray display
Pos. Position number display
Barcode ID Barcode ID display
Specimen Specimen kind display
Display test result.
(Item) ¾ If the test result is out of normal range or panic range,
displays error flag..
¾ As for check flag, refer chapter 6 Alarm function.

4-41

V1.00
ᬉ Search button 㸸Searched screen is popup.
Pop-up screen.
ᬊ Seach screen 㸸 Input search condition.
Search condition input
Sample Tray ▼ Sample tray number selection
Sanple Position
Sample position number selection
From ▼ to ▼
Barcode ID
Bar code ID input
From㸸 To㸸
Patient Name Patient name input
Patient ID Patient ID input
Search starts
OK
¾ Display of searched results.
Cancel Close search screen.
ᬋ Print (External printer) 㸸Print test results which are currently displayed.
ᬌ Exit 㸸Close result screen.
4-42

4-2. Data List - Patient History screen
¾ Test result history display, search, and print for individual patient
¾ To use Patient history, Patient ID input is necessary, in order screen.

ճ ղ

ձЍ

Result screen

մData list – Patient History screen

յ շ ո

Ў Ў Ў

յ
Ў
նSearch screen
նSearch screen
Ћշ
Ћո
ᬅ Result button 㸸Result screen is shown.

ᬆ Data List button 㸸Data list menu screen is popup.
Pop-up screen
ᬇ Data List menu screen
Patient History button㸸Displays test result history for individual patient.
¾ Displays history rsults for searched patient.
Print out screen for individual patient
Pop-up screen
ᬈ Patient History screen
Contents
Patient Name Patient name display
Patient ID Patient ID display
Item Test item name display
Specimen Specimen kind display
4-43

V1.00
Contents
(File date) Display test results.
Dil Dilution ratio display.
LH If the test result is out of normal range or panic range,
displays error flag.
¾ As for check flag, refer chapter 6 Alarm function.
ᬉ Search button 㸸Searched screen is popup.
Pop-up screen
ᬊ Search screen 㸸Input search condition.
Search condition input
Patient ID Patient ID input
Search period selection
Date range ▼
¾ Select latest 6 times, 1, 3, 6 months, 1 year, all
Search starts.
OK
¾ Display of searched results.
Cancel Close search screen.
ᬋ Print (External printer)㸸Print test results which are currently displayed.
ᬌ Exit 㸸Close Patient history screen.
4-44

4-3. Data List - Single Report screen
¾ Patient report print contents (profile) setting, search and print

¾ To use Single report, Patient ID input, in Order screen, is necessary

ղ
ճ
ձЍ

screen
Result

մ յ

նЍ Ћշ
Data list – Single Report screen

ᬆ Data List button 㸸Data list menuscreen is popup.

Pop-up screen
ᬇ Data List menu screenSingle report button.
㸸Patient report printing contents (Profile) setting,
search and printing button screen display
Pop-up screen
ᬈ Single report screen 㸹Profile setting of single report.
Setting, search condition input
Profile㸸 ▼ Select profile name (Profile 1 – 8)
Item name which is registerd in profile
In left side‫ڧ‬box
display.
Print In right side ‫ ڧ‬box Item name display
Items ←Register selected Item to Profile.
→←
→Delete selected Item from Profile.
Change the printing order of selected Item.
↑↓
¾ Print from the top in order.
Save Store setting contents
4-45

V1.00
ᬉ Single report screen: Search

Setting, search condition input
Date:
Select the date to search.
From ▼ to ▼
Patient ID Input is essencial.
Search
From to Input Patient ID to search
Barcode ID
Input Barcode ID to search.
From to
ᬊ Print (External printer) 㸸Print test results which are currently displayed.
¾ When the auto-print is selected for single report
print in System screen, the patient report is
printed out by last profile setting.
ᬋ Exit 㸸Close single report screen.
4-46

4-4. Data List – Header㸭Footer screen
¾ Header and footer setting for Data list (Patient report) screen.

ղ

ձЍ

ճ

Header/Footer screen

ᬆ Data List button 㸸Data list menu screen is popup.
Pop-up screen
ᬇ Data list menu screen Header/Footer button.
㸸Set for header /footer in patient report printing.
Pop-up screen
ᬈ Header/Footer screen-Input and set the contents to be printed.
Setting contents
Name Input hospital name and so on.
Address Input hospital address.
Tel. Input hospital telephone number.
Fax Input hospital ax number.
Other Input comment.
Exit Close Header/Footer screen.
4-47

V1.00
5. Test result screen switching button
¾ Test result screen switching button

¾ Under Barcode mode, this button is not shown.
mode.
If Barcode mode is used, screen switching can be done by clicking Barcode ‫ۂ‬.

ձЍ

ղ

Result screen

ղ Buttons and functions
Content
Displays the first position of shown round.

Former search
button Displays test result screen, one step smaller
position number than current screen.
Displays test result screen of input position
Search button
number.
Displays test result screen, one step larger
Next search position number than current screen.
button Displays test result screen of position number
which is the largest day among file date.

4-48

4.4 Calibration screen
Clicking CAL button, calibration screen opens.

¾ CAL screen 㸸Display of the Calibration results.
¾ Standard button 㸸Display setting screen for calibration samples
(position, repetition) including standard sample
concentration.
¾ Cal Data button 㸸 Display of calibration result details.
4.4.1 The contens of CAL screen
ձЍ
ղ
մ յ
CAL screen
ᬅ CAL button : Display calibration screen.

ᬆ Display of the calibration Item, order and calibration result.
ᬇ Display of the calibration order button.
Calibration setting, standard sample concentration input button.
Calibration result list button.
ᬈ ISE calibration order and result display.
ᬉ Display of the QC Item profile, order all and clear buttons.
4-49

V1.00
6. CAL screen -Item order, results
¾ Clicking of CAL button, display of the calibration setting, order and results.

Ћղ
ձЍ
ճ
յ մ
CALscreen – Old calibration result screen (Except ISE)

ձ CAL button 㸸Display calibration screen.
ղ Specimen ▼ 㸸Select Specimen
ճ Display calibration Item order, results.
Contents
Round Display reagent round name
Specimen Select “Specimen”.
Display old calibration results.
‫ڧ‬Past result ¾ մAfter ࣞ, յselect Item
¾ Clilck ISE graph button for ISE Items
Item No. Display by reagent round and Display Item number
specimen selection
Item Display Item name
automatically.
The order status is
Blk.Odr. Order calibration blank sample
shown by blue color.
The order status is
Order Order calibration measurement
shown by dark blue color.
¾ Tray, calibration sample positionand repetition is set in Calb.setting screen.
Tray Display calibration tray number.
Display of the balnk sample position (left side) and
Upper
Blank repetition number (right side)
Lower Display of the blank sample result (Absorbance).
Display of the standard sample position (left side) and
Calibrator Upper
repetition number (right side)
1 㹼8
Lower Display of the standard sample result (Absorbance).
Display of the standard sample Lot number when using
Lot No.
reagent barcode.
Graph Display of the calibration graph screen.
4-50

7. CAL screen ― Graph screen
¾ Clicking Grap button,display of the calibration graph
ձЍ CALscreen
CALscreen – Graph screen
ᬅ CAL button 㸸Display calibration screen.

ᬆ Graph button ‫ڧ‬ 㸸Display of the selected Item graph screen.
ᬇ Graphscreen
Contents
Item ▼ Select Item number. (Display Item name)
Specimen ▼ Select “Specimen”.
Lot No. Display of Lot number which used in measurement.
Test Date Display of the calibration date.
Display of the calibration kind.
Type
¾ Type is able to change for simulation.
Display of the balnk and standard sample
Calibrator Conc.
concentration.
blank,1 㹼8
Abs. Display of the calibration result (Absorbance).
Abs.□ Input the absorbance value for calculation.
Display of concentration value by inputted value in
Conc.
Abs.box □.
Caluculation button Do calculation by inputted Abs. box □.
4-51

V1.00
8. Calibration order
¾ Order entry of calibration in this screen.
յ
Ћղ
ձЍ
ճ
CAL screen

ᬆ Specimen: ▼ 㸸Select Specimen.
ᬇ ,մ box 㸸Chek the Item box ࣞ for calibration order.

¾ The order status is shown by color in Blk.Odr.
blue and Order dark blue.
ᬉ Save button㸹Save the orderd Item in ճ, մ box.
4-52

9. Calib. settings screen
¾ Setting of calibration ( sample position and repetition), and input standard

sample concentration.
ձЍ
ճ
CALscreen – Standardscreen

ᬆ Standard button 㸸Display standard screen.
ᬇ Screen and functions
Contents
Item Select Item name from the Item list.
Specimen Select “Specimen” from the list.
Tray Select calibration tray (C1-C6) from the tray list.
Position and concentration of the standard samples.
Blank, Position Select the position for calibration sample (1-45).
Calibrator Asp. Select the repetition (1-10).
1 㹼8 Conc. Input the concentration of blank or standard sample.
Absorbance range of blank sample.
Setting of absorbance limit (Low, High) for balnk
sample.
Low
Abs. ¾ Display the error flag if the absorbance of balnk
High
sample is out of range. No check is done if the value
is zero or low and high values are the same.
Save Save the selected or inputted data.
Exit Close the calibration setting screen.
4-53

V1.00
10. Cal Data screen
¾ Display of the calibration result list.

¾ The calibration results list is shown by date.
ղ
ձЍ
ճ մ
CALscreen – Cal Datascreen

ᬆ Cal Data button 㸸Display of Cal Data screen
ᬇ Cal Data Screen
Contents
Test date ▼ Select the calibration date.
Date/Time Display of calibration date and time.
Item Display of Item name.
Specimen Display of “Specimen”.
Dissply of the Lot number for calibration measurement
Lot No.
when using the reagent barcode.
Tray Display of the tray for calibration measurement.
Display of the sample position for calibration
Pos.
measurement.
Result Display of the calibration result (Absorbance)
Display the error flag if the error occured when calibration
Cal.Error measurement.
¾ Please refer to Chapter 6 Alarm information.
4-54

ᬈ Cal Data screen details 㸸Select the Item in the ճ list. Display of the details of
calibration result and calculation result.
Contents
Date/Time Display of calibration date and time.
Result Display of the calibration result (Absorbance)
Calculation results
Mean Display the value of Absorbance (Abs.) average.
CV Display of CV(㸣).
MAX Display of the maximum Absorbance㸦Abs.㸧.
MIN Display of the minimum Absorbance (Abs.).
յ Print㸦External printer㸧button㸹Print the Cal Data list to external printer.
ն Exit button : Close the Cal Data screen.
4-55

V1.00
11. ISE CAL screen - Order and result display
¾ Calibration order and result for the ISE Items.
Ћղ
ձЍ
մЍ
CAL screen

ᬆ Specimen ▼ 㸸Select Specimen.
ᬇ ISE Cal screen 㸸Display of the ISE calibration results.

Contents
Chek the ISE Item box ࣞ for calibration order.
Order
¾ Order status is shown by blue color.
Na㸭K㸭Cl Display of the calibration results.
ᬈ ISE graph button : Display of the ISE calibration graph screen.
4-56

12. ISE graph screen
¾ Clicking of ISE graph button, ISE calibration graph is shown.
ձЍ
¾
¾
¾
¾
¾
ղ
¾
CAL screen
ճ
CAL screen – ISE graph screen

ᬆ ISE graph button 㸸Display of ISE calibration graph.
ᬇ ISE graph screen
Contents
Specimen Select “Specimen”.㸦SerumࠊUrineࠊDialysis㸧.
Exit Close the ISE calibration graph screen.
Vertical axis㸹Calibration value =Slope value
(Graph) (mV/dec.)
NaࠊKࠊCl Horizontal axis㸹Calibration times
Date Display calibration date.
Value Display calibration value (Slope value).
4-57

V1.00
13. Calibration profile, Order all and cancel button
¾ Perform the calibration order entry by profile, order all or cancel in one time.
¾ Please refer to Chapter 4. 4.9 Profile setting.
¾ The ISE Items can not order or cancel in one time.
Ћղ
մЍ
ձЍ
CAL screen

ᬆ Specimen ▼ 㸸Select specimen.
ᬇ Buttons and functions 㸸Order or cancel by selection.

Contents
Blank Order Select for measurement order of calibration blank.
General Order Select for measurement order of Item.
Select all Enter for all test Items on this screen.
Clear all All the ordered Items are canceled.
Calibration order entry for profile registration Items
previouly.
(Profile name) ¾ Profile can be set maximum 8 set.
¾ Please refer to System screen-profile for profile
setting.
¾ The ordered Item turns to blue or dark blue.
ᬈ Save button : Save the calibration order entry.
4-58

4.5 QC screen
¾ QC sample measurement setting screen (parameter setting, order entry,

measurement and results) displays.
¾ QC is controlled by WESTGARD MULTI-RULECHART method.
4.5.1 QC screen contents
¾ Display Controls (Order QC, Current QC, QC History, and Control setting).
Display each screen by clicking buttons..
ձЍ
ճЍ
QC screen―Order QC. Screen
ᬅ QC button 㸸Display QC screen

ᬆ Screen and functions
Contents
Order QC Entry the order of QC sample.
Current QC Display latest QC result list.
QC History Display day to day QC results.

Setting for the QC measurement.
¾ Input for control sample name and setting of using QC
sample.
Control settings
¾ Measurement position of QC sample.
¾ Input of mean, SD, Max and Mini for QC sample.
¾ Profile setting for QC sample.
ᬇ QC Start button 㸸 Starts the QC sample measurement.
4-59

V1.00
4.5.2 Order QC screen
¾ Display of order entry screen for QC sample.

ղЎ
յ
ձЍ
Ћո
մ
շ
ն
QC. screen―Order QC. Screen
ᬅ QC button 㸸Display QC screen

ղ Order QC button 㸸Order entry for QC sample.
ճ Display of profile information for QC sample..
¾ Profile of QC sample is set in Control settings screen.
Contents
Round Display of reagent round.
Select control name of QC sample.
Control ▼ ¾ Display control name which registerd in control settings
screen.
Select sample tray round and sample position.
Position ▼
¾ Display of selected profile position.
㸡of Asp ▼ Select aspiration time. Maximum 10
Order
Sample state Sample state display Run
Complate
Erro (Error has detected)
Order (First test)
Order state Display of order entry status
Re-run order
մ Display of test Item 㸸The back color of ordered Item changes to blue.
¾ When select control name, order the test Items
which set in control settings screen automatically.
ᬉ Select all 㸸Order entry for all test Items of QC sample on this screen.
Clear all 㸸Cancel for all test Items of QC sample on this screen.
4-60

ᬊ Order QC button : Order entry by clicking Order QC button after Item

selection.
Contents
Clear Invalidate the input.
Delete Delete the order entry of QC sample.
Order Order entry of QC sample.
ᬋ Tray Icon : Confirmation of QC sample position.

The color of ordered Item changes to blue.
¾ QC tray can be selected “ON” in System parameter.
࣭Select the tray kind.
Patient tray : Gray
QC tray : Pink
Calinration tray : Yellow
࣭Select the tray number.
Patient tray : 1-50
QC tray : Q1-Q3
Calinration tray : C1-C6
ᬌ Order entry switching button

¾ Display QC order screen which set in QC settings screen.
Contents
Former search Display order entry screen of former position
button from current screen.
Search button Display order screen of inputted position.
Display order screen of next position from

Next search button
current screen.
4-61

V1.00
4.5.3 Current QC screen
¾ Display of QC results.
¾ The latest test results of selected QC samples are shown.

ղЎ
յ մ
ձЍ
QC. screen ―Current QC. screen
ձ QC button 㸸Display of QC screen

ղ Current QC button 㸸The latest test results of selected QC samples
are shown.
ճ Screen and functions
Contents
Control Name ▼ Select QC profile name.
Lot No. Display of QC lot number..
Exp. date Display of QC sample effective date.
Date / Time Display of tested date and time.
Select and order the rerun Item.
Rerun ¾ Blue color in the box shows rerun status.
¾ Rerun order is possible within a day.
Item Display Item name.
Display of sample tray and position number.
Pos.No.
¾ Tray (left) ̽ Position number (right)
Result Display of QC sample result.
Unit Display unit.
Min Displays the minimum value of control range
Max Displays the maximum value of control range

C 㹼 AB If error occurred, chenage the color to red.
Approval The results are refrected to QC history screen.
մ Save button 㸸Order entry of rerun.
4-62

յ Print External printer㸧㸸Print latest results of QC sample.

4-63

V1.00
4.5.4 QC History screen
¾ Display of day to day QC results by graph and list.

¾ Display of the results which is approved in currect QC screen.
Two QC sample results are shown in one screen.
ղЎ
ճЍ
ո ո
մ մ
ձЍ
յ յ
ն ն
Ћշ Ћշ
QC History (Graph) screen
QC History (List) screen
ձ QC button 㸸Display QC screen

ղ QC History button 㸸Display Cumelative QC screen
ճ Graph List button 㸸Display of graph or list screen for two QC samples.
ᬈ Screen and functions
Contents
Item ▼ Select Item name
Control Name ▼ Select QC profile name
4-64

Contents
Lot No. ▼ Display of QC sample lot number.
Run date: From ▼ to ▼ Select the starting date and ending date.
ᬉ մDisplay of Statistical calculation result

Contents
Test Test number display in the set range.
Mean Mean display in the set range.
SD Standard deviation display in the set rang.
Statistical
CV(%) Variation coefficient display in the set rang.
calculation
result Min Minimum value display in the set range.
Max Maximum value display in the set range.
(Maximum value – minimum value) display in the set
Range
range.
Exp. Effective date of set QC sample display
ᬊ Display of QC results by graph and list.

Graph
¾ Westgard mark displays on the top.
Westgard
Contents
mark
If QC sample data exceeds +/-2SD, random error is in
A
expectation.
If QC sample data exceeds +/-3SD, accidental error is in
B expectation.
¾ Random error is in expectation.
If two kinds QC sample data exceeds 2SD in the same direction,
or tow continuous data of the same QC sample exceeds 2SD in
C
the same direction, systematic error is in expectation.
¾ Systematic error is in expectation.ࠋ
If the SD range of two kinds QC sample data exceeds 4SD, or SD
D range of the same QC sample data exceeds 4SD.
¾ Systematic error is in expectation.
Four continuous data of the same QC sample exceeds 1SD in the
E same direction.
¾ Random error is in expectation.
Ten continuous data of the same QC sample appears in
F the same direction.
¾ Systematic error is in expectation.
Random error = Unstable QC result which happens by contamination,

delicate environmental difference and undefined reason.
It is difficult to remove the reason which suspects the
cause.
4-65

V1.00
Systematic error =The QC result shows partiality from the true value.
It happens by improper standard sample and reagent,
influence of interference substance and incomplete
tuning of the analyzer.
List
Contents
Date / Time Display of tested date and time.
Result Display of QC sample result.
Delete Delete the QC result in QC history screen
ᬋ Graph screen switching button (Display in graph screen)

Contents
Display test result of former date from current
Former search button
screen.
Display test result of after date from current
After search button
screen.
ᬌ Print (External printer) : QC screen is printed out for graph and list.
¾ Print both of graph and list. (Upper part is graph and down part is list)
¾ Print 30 times results in one page.
4-66

4.5.5 Control settings screen㸦QC sample setting screen㸧
¾ QC sample setting screen display.

1) Control name and setting of control.
2) Setting of measurement position.
3) QC parameter setting. (MeanࠊSDࠊMinࠊMax)
4) Setting of QC profile.
ղЍ յ
ձЍ
Q.C.screen―Control settings screen
ձ QC button 㸸Display QC screen

ղ Control settings button 㸸Control input screen is shown.
ճ Setting for the following QC Items.
Contents
Select QC profile number. From 1㹼30
Control name ▼
Input profile name. Max16 character
Select “Specimen”
Specimen▼
(Serum, Urine, Plasma, CSF, Dialysis, Other, HbA1c)
Lot No. Input lot number of QC sample. Max 8 character
Check the box ࣞ when input the expire date.
Exp.Date
Select effective date of QC sample from calendar.
Select tray and QC sample position.
Tray Tray No. Position No.
Patient 1 – 50 31-45
Calibration C1-C6 31-45
Pos.1㸸▼- ▼㹼
QC Q1-Q3 1-45
Pos.6㸸▼- ▼
¾ When using the QC tray, turn on the QC tray in
System
screen. Please refer to Chapter 4, 4.9.6 System
setting screen.
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մ Setting of Item and parameters: Input Item and control value.

Contents
Item Display of Item name
Profile Select the Item by clicking check box ࣞ for QC profile entry.
Mean Input mean value for result check.
SD Input standard deviation.
Min Minimum value is inputted automatically.㸦Mean㸫2SD㸧
Max Maximum value is inputted automatically.㸦Mean㸩2SD㸧
յ Delete button and Save button

Contents
Delete All the profile setting is deleted.
Save All the profile setting is stored.

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4.6 Reagent screen

¾ Display of setting for reagent bolltle and confirmation of bottle information.
1) Bottle info. Screen : Input reagent round, bottle information (tray),
renewal bottle and expire date.
2) Reagent settings screen : Setting for reagent bottle (Reagent tray round,bottle
position.
4.6.1 Reagent screen
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Reagent screen―Bottle Info screen
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Reagent screen Reagent setings screen
ᬅ Reagent button : Display reagent screen.

ᬆ Bottle Info. button : Display of reagent bottle information screen.
ᬇ Reagent Settings button :Display of reagent setting screen.
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4.6.2 Bottle Info. screen㸦Reagent bottle information screen㸧

¾ Setting for reagent round, bolltle information (tray), renewal and expire date.

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Reagent screen―Bottle Info screen
ᬅ Reagent button : Display reagent screen.

ᬆ Bottle Info. button : “Bottle Info.” screen is shown.
ᬇ Screen and functions : Display of bottle information, reagent remain and
expire date.
Contents
Select reagent round. From 1 to 10
Round name ▼ Display of reagent round name.
¾ Input round name is possible. (Max10 character)
Bottle position number is shown.
¾ Position number for each reagent tray.
Pos.
24 Item tray;1 - 24
36 Item tray; 1- 36
Item No. Display of Item number.
Item name Display of Item name.
Bottle Display 1 for mono reagent and 2 for double reagents.
R1 Display of reagent remaining of R1.
R2 Display of reagent remaining of R2.
¾ Back color changes depending on reagent residual volume level.
¾ The alarm level and sampling stop are set in System screen. Please refer to
Chapter 4, 4.9.6 System setting.
White Enough reagent volume
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Contents
Exp.Date Reagent expire date is shown.
Exp. date(open) Reagent expire date after open is shown.
¾ Back color of over expired date changes to red.
¾ Reagent barcode information is shown after reading of reagent barcode.

Lot No. Reagent lot number is shown.
When above two reagent bottles of the same Item, sampling
priority number are shown.
¾ Set the priority by setting order, and use from priority
Priority
1.
¾ If the reagent remaining is below sampleing stop, move
to next bottle.
ᬈ Reagent remaining renewal and save button.

Contents
Residual test volume of the selected Item is input
Fill automatically.
¾ Renewal of R1 and R2.
Residual test volumes of all Items are input automatically.
Fill All
Save Displayed reagent informations are registered.

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4.6.3 Reagent settings screen㸦Reagent bottle setting screen㸧
¾ Reagent settings screen displays.

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Reagent screen ̿Reagent setings screen
ձ Reagent button : Display reagent screen.

ᬆ Reagent Settings button : Display of reagent bottle setting screen.
ᬇ Reagent tray position screen : Display of reagent tray position and Item
name
¾ Select tray position and register the Item
from Item list.
Contens
Select reagent round number. From 1 to 10
Round name ▼ Display of ragent round name.
Max 10 character
¾ Input round name is possible.
Display of reagent tray position number.
24 Item tray, 1㹼24
1㹼36(24)
36 Item tray, 1㹼36
[Item name]
¾ Display of registered reagent Item.
¾ Back color of selected Item changes to blue.
ᬈ Display of registered Item list.
ᬉ Renewal of reagent volume and redister button.
Contents
Residual test volume of the selected Item is input
Fill automatically.
Residual test volumes of all Items are input automatically.
Fill All
Display when using the reagent barcode.
Bottle Read
¾ Reading of reagent bottle barcode.
¾ Reagnt barcode setting is set in system screen.
Please refer to Chapter 4, 4.9.6 System setting.
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Contents
Clear bottles Reagent bottle information is deleted.
Clear round Reagent round information is deleted.
Save Displayed reagent informations are registered.
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V1.00
4.7 Item screen
¾ Item parameter information screen is shown.

¾ This screen is used for setting of analysis condition depending on each Item.
Note: Item parameter is necessary for setting of each specimen by different Item No.
4.7.1 Item screen contents
¾ The following selection buttons are shown. Each screen appears by ckicking each
button.
1) Optical : Optical test Items
2) ISE : ISE (Na, K, Cl) Items
3) HbA1c : HbA1c Items
4) Calculation : Calculation Items
5) Others : Serun information, detergent, diluent and lysing
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Item screen―Optical screen
ᬅ Item button :Item screen is shown.

ᬆ Screen and functions
Contents Item number
Optical test Items parameter input
Optical 1㹼77
screen.
78㸻Na
ISE (Na, K, Cl) Items parameter input
ISE 79㸻K
screen.
80㸻Cl
101,102=Latex
HbA1c HbA1c Items parameter input screen
106㸻Enzyme
Calculation Items parameter input
Calculation 81㹼95
screen.
Serum information(L-H-I), detergent, diluent
Others ―
and lysing parameter input screen
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4.7.2 Optical screen
¾ Item parameter input screen.

¾ Item parameter needs to set for each specimen.
Note: Item parameter is necessary for setting of each specimen by different Item No.

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Item screen―Optical screen
ᬅ Item button : Item screen is shown.

ᬆ Optical button : Display of optical Item screen.
ᬇ Input test conditions
Contents
Item No. ▼ Select Item number 1㹼77
Item name Input Item name Max 8 characters
Select “Specimen”.
Specimen ▼
(Serum, Urine, Plasma, CSF, Diarlysis, Other)
Data information
Units Input unit Max 8 characters
Decimals Input decimal point 0㹼3
Analysis
Type ▼ Select analysis type END method or RATE method
Main wave ▼ Select Main wavelength Select from following wavelengths
Sub wave ▼ Select Sub wavelength both Main and Sub wavelength.
(340,380,405,450,480,505,546,570,
600,660,700,750,800nm)
Correlation Input correlation value.
(Y=AX+B)
A= Input slope Default value= 1
B= Input intercept Default value=0
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Contents
Blank value
‫۔‬Water○Reagent Select “Water” normally Default=Water
Calibration Calibration setting
Type Select calibration kind.
¾ Factor,Liner1,Liner2,Exponential,Spline,Polynomial,
Logit1,Logit2
In case of Factor Input for Factor calibration.
Factor Input “Factor value”
¾ Input calculculated value of light pass length 10 mm.
¾ Add – (minus) for decrease reaction.
In case of Linear1 Display for Liner1 calibration. Input acceptable range.
¾ Calibration error appears when the calibration result is
out of range.
Factor Min Input minimum value of calibration factor.
Factor Max Input maximum value of calibration factor.
Factor=Standard sampleconc./(Standard–Blank sample)Abs.
CV( Max) Input acceptable CV(%).
¾ Absolute value is compared for error flag.
Aspiration Input aspiration volumes.
¾ Reaction volume range;140μL㹼400μL
Type ▼ Select “Single” or “Double”.
Vol.(μL)
Sample Input sample volume 2.0㹼25μL㸦0.1μL step㸧
Reagent1 Input reagent 1 volume 140㹼300μL(1μL step)
Reagent2 Input reagent 2 volume 20㹼260μL(1μL step)
Bottle(mL) Input reagent 1 and regant 2 bottle volumes.
¾ Reagent remain is calculated by inputtrd volume.
Reagent1 36Item tray
Reagent2
24Item tray
(Option)
First dil.
Dilution ratio
Sample ▼ Select dilution ratio for
0.5,6,10,20,30,40,50,60,70,80,90,
first run.
100
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Contents
Data Process Input data process condition.

Read Input reading range.
Main start Input starting test point for main reading.

Main end Input ending test point for main reading.
Sub start Input starting test point for sub reading.
Sub end Input ending test point for sub reading.
¾ Reading point range
Abs.Limit □to□ Input lower and upper limit values.

¾ Range -3.0㹼3.0 Abs.
¾ Input lower limitӌupper limit
Check value
End point limit Input limit value to check optical absorbance upper limit.
¾ Input range -3.0㹼3.0 abs.
Linear check(%) Input linearity standard value.
¾ Input above 0.
Prozone check Prozone phenomenon check parameter input area, for
immuno-reaction.
First start/end Input starting and ending test points of basic test
interval. (Input range 34㹼54 points)
Second start/end Input starting and ending test points of reference test
Limit(%) Input comparison limit value(%).
¾ Limit value(%)=Second range slope/First range slope x
100.
¾ The slope is calculated by the least square method.
○High ‫۔‬Low Select the check level for high or low limit.
Minimum Abs. Input no prozone check conditions.
Mean Input the minimum Abs. average value of main wavelength.
Variate Input the minimum slope value of main wave length.
The valiation is calculated by the least square method.
¾ No prozone check is done if the value below the input
value.
¾ No prozone check is done if the slope value of the first
interval is below zero.
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Contents
Reference Interval Input for reference interval.
Male low㸭 high Input of lower and upper limit of male.
Female low㸭 high Input of lower and upper limit of female.
Panic Range Input panic range.
Qualitative Value Condition setting of concentration result
transforms to qualitative result.
Male㸭 Female ¾ Lower and upper limit of male or female can
2- 㹼3+ be set.
¾ Input conc. result to transformation.
Reaction check Setting of the abnormal reaction check.
○ON ‫۔‬OFF Select “ON” when check the abnormal Abs..
Check Input checking point.
¾ Input range 10㹼54 points
Low Input lower limit of the check range.
¾ Input range -3.0㹼3.0Abs.
High Input upper limit of the check range.
¾ Input range -3.0㹼3.0Abs.
Judgement of VL/VH In case of selected ON for multi calibration.
VL ○ON/‫۔‬OFF The result lower than blank or standard lowest
sample conc. appears VL flag.
VH ○ON/‫۔‬OFF The result upper than highest standard sample
apperas VH flag.
Auto rerun Select “ON” for setting of the auto-rerun.
○ON ‫۔‬OFF Following settings are essential for auto-rerun.
¾ Auto Rerun switch set to ON in System screen.
¾ Set diluent bottle for dilution rerun in reagent
screen.
Auto rerun condition Input concentration for auto rerun.
Low/High,Re, If the result lower than low limit or upper than high
Value, Dil limt proceeds auto-rerun automatically.
¾ Select when perform rerun. Back color changes to
Re
blue after order entry.
Value Input conc. values for auto-rerun.
Dil. Select dilution ratio for auto-rerun.
¾ 0.5, 6,10,20,30,40,50,60,70,80,90,100
¾ The blank coloum proceeds auto-rerun without
dilution.
¾ Select lower dilution ratio than first dilution for
low value auto-rerun.
¾ Select higher dilution ratio than first dilution for
high value auto-rerun.
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Contents
Auto rerun condition
Set auto-rerun condition by Abs..
(Abs.)
If select on, the result Abs. lower or higher than Abs.
Lower/Higher
limit proceed the auto-rerun automatically.
○ON ‫۔‬OFF
Select dilution ratio.
Lower /Higher Dil. ¾ 0.5, 6,10,20,30,40,50,60,70,80,90,100,
¾ The blank coloum proceeds auto-rerun without
dilution.
Auto rerun condition Set auto-rerun condition by Prozone.
(Prozone)
○ON ‫۔‬OFF If select on, the result out of prozone limit proceed the
auto-rerun automatically.
Sample Vol. Input sample volume for using auto-rerun.
¾ Input range 2.0㹼25μL
Diluent
‫۔‬DIL 1 ○DIL2 Select dilution bottle for auto-rerun orsample dilution.
ᬈ Save and print buttons.

Delete button :Delete the displayed information.
Print㸦External printer) : Print out the Item screen to the external printer.
CSV button : Save the displayed information to CSV file.

Save button : Register the displayed information.
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4.7.3 ISE screen
¾ ISE parameter screen displays.

¾ Item parameter needs to set for each specimen.

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Item screen―ISE screen

ᬆ ISE button : ISE screen is shown.
ᬇ Screen and functions : Input conditions.
Contents
No.78㸻NaࠊNo.79㸻KࠊNo.80㸻Cl
Item No. Select Item number
The numbers are fixed.
Item name Input Item name Less than 8 characters
Select “Specimen”.
Specimen
(Serum, Plasma, Urine, Dialysis)
Data information
Units Input unit Less than 8 characters
Decimals Input decimal point Input range 0㹼3
Analysys
Type ISE(Fixed)
Correlation Input correlation
(Y=AX+B) value.
Reference interval Input for reference interval.
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Display and input contents

Auto rerun range
(conc.)
○ON ‫۔‬OFF Select “ON” for setting of the auto-rerun.
Following settings are essential for auto-rerun.
¾ Auto rerun switch set to ON in System screen.
¾ Set diluent bottle for dilution rerun in reagent screen.
Auto rerun range

Auto-rerun by using concentration.
(conc.)
If select ON, the result lower than low limit or upper than
low/high Re
high limt proceeds auto-rerun automatically.
¾ Back color changes to blue after the order entry.
Value Input conc. values for auto-rerun.

Calibration slope
range
low/high Input of lower and higher slope limit for the ISE calibration
range.
ᬈ Print button, Save button


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V1.00
4.7.4 HbA1c screen
¾ HbA1c Item parameter screen displays.

¾ Select Item parameter based on the reagent specification.
࣭Item No.101 or No.102 is used for Latex method.
࣭Item No.106 is used for enzymatic method.
1. HbA1c screen㸦For Latex reagent Item No.101,102)
¾ Ratex method Item parameter screen displays.

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Item screen―HbA1c(Latex reagent) screen
ᬅ Item button 㸸Item screen is shown.

ᬆ HbA1c button 㸸HbA1c parameter input screen is shown.
ᬇ HbA1c screen 㸸Select Item No.101 or 102.
ᬈ Display input screen
Contents
Select Item number.
Item No.
¾ No.101 or No.102
Input Item name
Item name ¾ Max 8 characters
¾ Same name is not acceptable.
Data information
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Contents
Analysis
Select analysis type
Type END method or RATE method
Select main wavelength
Main wave Select from following
Select sub wavelength wavelength both main and sub
Sub wave
wavelength.
(340,380,405,450,480,505,546,
570,600,660,700,750,800nm)
Correlation
(Y=AX+B) Input correlation value.
A= Input slope Default value: 1
B= Input intercept Default value:0
Blank value
‫۔‬Water○Reagent Select “Water” normally Default:Water
Logit1,Logit2
In case of Factor Input for Factor calibration.
In case of Linear1 Input for Liner1 calibration.
Error appears when the calibration result is out of range.
Factor=Standard sample conc./(Standard–Blank sample)Abs.
CV Max Input acceptable CV(%).
Absolute value is compared for error flag.
Aspiration Input aspiration volumes.
¾ Total reaction volume 140μL㹼400μL
Type ▼ Select “Single” or “Double”.
Input aspiration levelof red blood cell from the bottm of
Level
primary tube.
¾ Default: 2mm
Vol.(μL)
Sample Input sample volume of red 2.0㹼25μL㸦0.1μL step㸧
blood cell.
Lysing Input lysing solution volume. 140㹼300μL㸦1μL step㸧
Sample Input hemolysed sample 2.0㹼25μL㸦0.1μL step㸧
volume.
Reagent1 Input R1 volume. 140㹼300μL(1μL step)
Reagent2 Input R2 volume. 20㹼160μL(1μL step)
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Contents
¾ Reagent remain is calculated reffering inputtrd volume.
Reagent1 36 Item tray
Reagent2
24 Item tray
Data Process Input data process condition.

Read Input reading range.
Main start Input starting test point for main reading.
Main end Input ending test point for main reading.
Sub start Input starting test point for sub reading.
Sub end Input ending test point for sub reading..

Check value
End point limit Input the value to check optical absorbance upper limit.
Linear check (%) Input linearity standard value.
¾ Input above than 0.
immuno-reaction.
First start/end Input starting and ending test points of basic test i
nterval. (Input range 34㹼54 points)
Second start/end Input starting and ending test points of reference t
est interval. (Input range 34㹼54 points)
Limit(%)
Input comparison limit value(%).
100.
○High ‫۔‬Low Select high or low limit.
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Contents
value.
¾ No Prozone check is done if the slope value of the first
Panic range Input panic range.
ᬉ Print button, Save button


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V1.00
2. HbA1c screen㸦For enzymatic reagent Item No.106)
¾ Enzymatic method Item parameter screen displays.

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Item screen―HbA1c (Enzymatic method) screen
ᬅ Item button 㸸Item screen is shown.

ᬆ HbA1c button 㸸HbA1c input screen is shown.
ᬇ HbA1c screen 㸸Select Item No.106.
¾ Display of parameter input screen for HbA1c
enzymatic method.
¾ Hb, A1c, HbA1c Items are shown.
Screen and functions
Contents
Item No. Select Item number
¾ No. 106
Item name Input Item name
¾ Less than 8 hcaracters
¾ Same name is not acceptable.
ᬈ HbࠊA1c input Items㸹 Hb,A1c are the same.
Display and input contents
Data Information
Analysis
Type Select analysis type END method or RATE method
Main wave Select main wavelength Select from following wavelength
Sub wave Select sub wavelength both main and sub wavelength.
(340,380,405,450,480,505,546,570,
600,660,700,750,800nm)
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Contents

Logit1,Logit2
¾ In case of Factor Input for Factor calibration.
¾ In case of Input for Liner1 calibration.
Linear1 Calibration error appears when the calibration result is out
og range.
CV Max Input acceptable CV(%).
Correlation Input correlation value.
(Y=AX+B)
Blank value
‫۔‬Water○Reagent Select “Water” normally Default:Water
Input data process condition.
Data Process
Input reading range.
Input starting test point for main reading.
Main start
Input ending test point for main reading.
Main end
Input starting test point for sub reading.
Sub start
Input ending test point for sub reading..
Sub end


Check value
End point limit Input limit value to check optical absorbance upper limit.
Linear check(%) Input linearity standard value.
¾ Input range above 0.
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V1.00
Contents
immuno-reaction.
First start/end Input starting and ending test points of basic test
Second Start/End Input starting and ending test points of reference test
Limit(%) Input comparison limit value(%).
100.
○High ‫۔‬Low Select high or low limit.
value.
¾ No Prozone check is done if the slope value of the first
Sensitive range Input sensitive conc. of Hb and A1c.
Male/Female The result lower than input limit, B flag appears.
Lower/Upper The result higher than input limit, G flag appears.
ᬉ HbA1c input parameter

Contents
Data Information
Decimals Input deciamal point Input range 0~3
Calculation Input calculation formula of HbA1c
Item1㸦a㸧 Item1 for calculation. Fixed to Hb.
Item2㸦b) Item2 for calculation. Fixed to A1c.
Calculation Input calculation formula for HbA1c.
Aspiration Input aspiration volume.
¾ Total reaction volume 140μL㹼400μL
Type Select single or double reagent.
Level Input aspiration levelof red blood cell from the bottm of the
primary tube.
¾ Default 2mm
Vol.(μL)
ձ ղ
ձSample Input sample volume of red blood 2.0㹼25μL㸦0.1μL step㸧

cell.
Lysing Input lysing solution volume. 140㹼300μL㸦1μL step㸧
ղSample Input hemolysed sample volume. 2.0㹼25μL㸦0.1μL step㸧
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Contents
Reagent1 Input R1 volume 140㹼300μL(1μL step)
Reagent2 Input R2 volume 20㹼260μL(1μL step)
¾ Reagent remain is calculated reffering inputtrd volume.
Reagent1 36 Item tray
Reagent2
24Item tray
Reference range Input for reference range.

Male low㸭 high Input lower and upper limit of male.
Female low㸭 high Input lower and upper limit of female.
Male low㸭 high Input lower and upper limit of male.
Female low㸭 high Input lower and upper limit of female.
Lysing check Check the hemolysed sample condition.
When the result upper than check value, AB flag appears.
○ON ‫۔‬OFF Select ON for check the condition.
First start/end Input starting and ending test points of basic hemoly
sed interval.
¾ Input range 10㹼54 points
Second start/end Input starting and ending test points of reference
interval.
Check ¾ Input range 10㹼54 points
Input the check value for hemolysing.
¾ Calculation formula
Second(Mean)-First(Mean)×K factor/A1c result×100
ᬊ Print button, Save button


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V1.00
4.7.5 Calculation Screen
¾ Calculation Item parameter screen displays.

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Item screen―Caluculation screen

ղ Caluculation button : Calculation input screen is shown.
ᬇ Screen and functions : Setting for Item and calculation formula.
Contents
Item No. Select Item number Selection No.81㹼95
Item name Input Item name Less than 8 characters
Serum, Urine, Plasma
Specimen Select specimen
CSF, Diarlysis, OtherHbA1c
Data information
Decimals Inp@ut decimal point Input range 0㹼3
Calculate
Item 1(a)㹼6(f) Dispaly Item name.
¾ Select from the Item List.
¾ 6 Items can be use.
Calculation formula Input calculation formula.
¾ Follow the information on the screen.
Item List Display of optical Item list.
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ᬈ Print button, Save button


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V1.00
4.7.6 Other㸦Serun information, detergent, diluent, lysing solution screen㸧
¾ Serun information, detergent, diluent, lysing solution screen display.

¾ Parameters are set default.

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Item screen―Other screen

ᬆ Other button 㸸 Display of Serum information(L-H-I),
Deterent(wash 1-3), Diluent, Lyzing screen.
¾ Item parameters and Intem number.

Item screen - Other Itemname Intem No.
Serum information Serum
L-H-I 96
parameta Information
Wash 1 Wash 1 113
Detergent parameta Wash 2 Wash 2 114
Wash 3 Wash 3 115
DIL 1 111
Dilution parameta Dilution
DIL 2 112
Lysing parameta Lysing Lysing 99
ᬇ Serum information parameta screen

Display of lipemic, hemolise and Icteric parameters for affects the result of
serum sample.
¾ The parameters are fixed in the program.
¾ Please change the setting if the result is shown difference between
analyzer and visual results.
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Contents
Bottle(mL) Input bottle volums for serum information Item.
¾ Residual reagent is calculated by inputted volume.
36 Item tray
24 Item tray
(option)

Qualitative value ¾ Please change the setting if the result is shown
difference between analyzer andvisual results.
Lipemia / 2- 㹼3+ Lipemia; Display of transferred qualitative value.
Hemolysis / 2- 㹼3+ Hemolysis; Display of transferred qualitative value.
Bilirubin / 2- 㹼3+ Bilirubin;㸧Display of transferred qualitative value.
ᬈ Detergent㸦Wash1㹼3㸧screen.
Input wash parameter to contamination avoidance.
¾ Wash 1 to 3 are common.
¾ Sample volume is fixed to 25 uL.
Contents
Reagent1㸭Reagent2 Reagent1
Input detergent volums
Vol.(μL) 140㹼300μL㸦1μL step㸧
to avoiding reagent
Reagent2
contamination.
20㹼260μL㸦1μL step㸧
Bottle(mL) Input detergent bottle volumes.
¾ Residual reagent is calculated by inputted volume
¾ Fixed to double reagents.
36 Item tray
24 Item tray
(option)
ᬉ Diluent㸦Dilution solution㸧screen
Input bottle volume to using sample dilution.
Contents
Dil1㸭Dil2 Input diluent bottle volum.
Bottle(mL) ¾ Residual reagent is calculated by inputted volume.
36 Item tray
24 Item tray
(option)
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V1.00
ᬊ Lysing㸦Lysing solution㸧screen
Input Lyzing bottle volume to using HbA1c measurement.
Contents
Bottle(mL)
Lysing ¾ Residual reagent is calculated by inputted volume.
36 Item tray
24 Item tray
(option)
ᬋ Print button, Save button


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4.8 Maintenance
¾ Maintenance information displays.
4.8.1 Maint.screen
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Mainte screen
ձ Maint. button 㸸Maintenance screen is shown.

ղ When the causor is pointed the button, maintenance information displays.
¾ When Auto-gain measurement displays gain values for details.
ճ Maintenance Item
Buttons Contents
All the filling lines are filled with water.
¾ This function is used at the system set up or the piping
PRIME
tubes exchange.
¾ Wash time is about 3 minutes.
Purified water or cleaning liquid will be distributed to all of
Fill Cells the reaction cell from the R1 probe.
¾ Dispensed time is about 5 minutes.
All the reaction cuvettes are drained.
Drain Cells
¾ The required time is about 5 minutes.
All of 60 reaction cuvettes are washed.
Wash Cells ¾ Wash by all cell washing system.
Each probe washing is performed.(Sample,Reagent 1
and 2 probe)
¾ Set 500 uL of detergent at wash 1 position on the
Probe Wash 1
sample tray.
¾ Set the Wash1 bottle to the reagent tray.
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V1.00
Contents
Each probe washing is performed.㸦 Sample,Reagent 1
and 2 probes)
Probe Wash 2
¾ Set detergent tube at tray position 30 on the sample
(For HbA1c Item
tray. (Pour the detergent till 40 mm hight.)
probe washing)
¾ Set the Wash1 bottle to the reagent tray.
All the reaction cells and probes are washed in the
same procedure as measurement by aspiration and
dispensation of wash1 detergent instead of reagent
and sample.
Special Wash 1 ¾ Set the Wash1 bottle to the reagent tray. (R1 bottle
20mL, R2 bottle 11mL)
¾ Set 2mL of detergent cup at Wash1 position on the
sample tray.
and sample.
¾ Set 2ml of detergent cup at Wash2 position on the
sample tray.
and sample.
¾ Set 2mL of detergent cup at Wash3 position on the
sample tray.
Auto Gain is performed.
Auto Gain
¾ Please refer to Chapter 4, 4.8.3 Auto-Gain
մ The progress is indicated by the time.

¾ ISE Mainte and ISE purge are not displayed the progress.
ᬉ ISE maintenance and functions.

Contents
Perform the ISEwash.
ISE Wash ¾ Set the ISE detergent at ISE wash position on the
sample tray before start.
The liquid of ISE line is drained.
ISE Mainte ¾ Perform before ISE maintenance when change the
electrode.
4-96

Contents
Fill the ISE line by calibrator1.
ISE Purge ¾ Perform after ISE maintenance when change the
electrode.
ն ISE CRS button : The CRS measurement is used for the ISE correlation.
Please refer to Chapter 4, 4.8.2. ISE CRS screen. (ISE
correlation measurement)
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4.8.2 ISE CRS screen (ISE correlation measurenment)
¾ The correlation measurement is recommended for ISE sample by usig CRS

sample.
¾ CRS is a standard sample for ISE method.
ձЍ
Maintenance screen ̿CRS parameter screen
ձ Maint. button 㸸Maintenance screen is shown.

ղ ISE CRS button 㸸CRS parameter screen is shown.
ճ Buttons and functions.
Contents
Specimen ‫ۂ‬ Select specimen Serum, Urine, Plasma
Repeat ‫ۂ‬ Select aspiration time. 3㹼10 times
Na L/M/H Input the Na conc. of low, medium and high.
K L/M/H Input the K conc. of low, medium and high.
Cl L/M/H Input the Cl conc. of low, medium and high.
Display following message.
Status Run ̽ CRS running
After measurement ̽ CRS success or CRS failure
Start the CRS measurement.
StartЍE.Stop ͤAfter the start of operation, and displays the E. Stop
button.
Close Close the CRS parameter screen.
ISE CRS correlation procedrue

1) Click ISE CRS button.
2) Display of CRS parameter screen.
3) Input CRS parameters (Specimen, Count, Conc. value)
4) Set the sample cups for each concentration sample on the sample tray.
(For setting N=5, 500uL)
4-98

¾ CRS Sanple positions are fixed in program.

31 = Low conc. sample
32 = Middle conc. sample
33 = High conc. sample.
5) Click Start button, and start the CRS measurement.
͆CRS running͇ is shown in state culoum.
6) ͆CRS success͇ or ͆CRS failure͇ is shown after measurement.
¾ If ͆CRS failure͇ is displayed, check and remove the reason of failure
and rerun.
7) Click Close, and close the CRS parameter screen.
8) Set the correlation values by using calculated results automatically.
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4.8.3 Auto gain screen information
¾ Autogain information screen displays. Please refer to Chapter 5 Auto gain.
ձЍ յ
Maint. screen
ᬅ Maint. button 㸸Maintenance screen is shown.

ᬆ Auto Gain control button 㸸Ayto gain screen is shown.
ᬇ Auto gain screen and functions. (Setting is unnecessary)
Contents
[CH] Display of channel number.
[Color] Display of wavelength.
[Offset] Display of offset value.
[Offset AD] Display of offset AD value.
[Gain] Display of gain value.
[Read AD] Display of read AD value.
Offset Target Display of the offset target value.
Gain Target Display of the gain target value.
¾ Following buttons can be operates under login of service engineer level.
Contents
Read AD Read the AD valu.
CW 1/2Pich To move clockwise by 1/2 pitch.
CCW 1/2Pich To move counter-clockwise by 1/2 pitch.
մ Confirmation screen 㸸Clicking Auto gain button, pop-up screen is shown.

Clicking OK button, start the auto gain
measurement.
յ Data saving confirmation screen
㸸After Auto gain completed, pop-up screen is
shown. Clicking OK button, auto gain results are
registered.
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4.9 System screen
¾ System setting screen displays for system parameter setting

4.9.1 System buttons
System parameter is indicated as follows.
ղЎ
ձЍ
System screen― Menu button
ձ System button 㸸Display of menu screen in System screen.

ղ System menu screen and functions.
Buttons Contents
Maintenance List Display of daily maintenance list.
Reaction Display of reaction monitor screen.
Display of profile registration screen for calibration
Profile
order and patient sample order.
Cell Blank Display of cell blank value. Confirm the cell condition.
Display of sytem parameter setting screen.
System Parameter ¾ Setting for run sequence, reagent tray and reagent
remain.
Display of the setting for carry over avoidance screen
Wash Settings
(Reagent and Sample probes, reaction cell)
Display of reagent barcode setting screen.
Reagent Barcode
¾ Display when the login by service engineer level.
Display of each unit movement and condition of
Manual Operation
analyzer status.
Display of temperature monitor and pre-heater for
Temperature
washing water and temperature setting screen.
Unit offset parameter values.
Initialization
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Buttons Contents
Display of operator level setting.
Authority Settings
Display of the version information on the system
Version
program.
Display of Log off screen.
Log off
Use for change the operator level.
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4.9.2 Maintenance List screen
¾ Maintenance list screen displays. Confirm the maintenance performaince.

ղЎ

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մЎ

ճ

Maintenance List screen

ղ Maintenance List button 㸸Display of Maintenance List screen.
Contents
Update the performed date.
‫ڧ‬ ¾ Check the box after performance. Clicking Save button,
update the performed date.
Select the operation period.
‫ۂ‬ ¾ Select from Daily, Weekly, Monthly, Half year, One year and
Two years.
(Details) Input operation details.
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Contents
(Last date) Display of the last performed date.
Display of the next date.
¾ Chek the box, and update the date by clicking Save
(Limit) button.
¾ If the date is not updated within period, the back color of
related button is change to red.
ᬈ Save button 㸸Update the performed date and next operation date.
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4.9.3 Reaction monitoy screen
¾ All the Reaction Abs. of each reading point and reaction graph are displayed.
The Abs. of Main, sub wavelength, main – sub wavelength and measurement
result.
¾ The reaction screen can be open form the result screen.

ղЎ

ձЍ

ճ

Ќ Ќ
Reaction screen (reaction monitor screen)
ն մ
Reaction monitor save screen
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V1.00
ᬅ System button 㸸Display of menu buttons in System screen.

ᬆ Reaction button 㸸Display of Reaction monitor screen.
ᬇ Reaction monitor information
Contents
Main Wave length
Used mainand sub wavelengths display
/ Sub wave length
Cell Blank/ Cell Blank Cell blank for main and sub wavelengths display
Main - Sub wave length (Display Abs. of Main - Sub wavelengs)
No. Display of measuring points. (1㹼54)
Display the optical absorbance resultof each
Abs. measuring points for Main and Sub waveleng
ths.
Display reaction monitor number.
¾ Change the monitor screen before after by
RC㸡㸺㸼 selection of 㸺 or 㸼 button.
¾ Display of reaction monitor by using RC No. in
Result Log screen.
Cell No. Display of used reaction cell number.
Sample tray No. Display of used sample tray number.
Sample pos. Display of used sample positionnumber.
Item No. Display of Item number.
Item name Display of Item name.
Display of the result value.
Result
¾ Display zero value for calibration result.
Display of reaction monitor graph.
(Graph) ¾ X axis is measuring points. Y axis is absorbance
value.
Abs. value setting for graph display.
Zero Level
¾ (Y axis) basic level(-9.999㹼9.999 Abs.)
Abs. value setting ofr graph display.
Span
¾ (Y axis ) sesitivity(-9.999㹼9.999 Abs.)

ᬈ CSV button 㸸Display of reaction monitor saving popup screen.
¾ Reaction moniotor can be save to CSV file.
Display of pop-up screen
յ Reaction monitor saving screen
Contents
○RC# ― . Input saving RC No.
○Date
Input saving date.
― .
OK Select port and save.
Cancel Cancel the saving.
ᬊ To Results button : Move to displayed monitor result screen.
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4.9.4 Profile screen
¾ Profile entry screen for patient and calibration sample displays.

ղЎ

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ճ

մЍ

A

Profile screen

ᬅ System button 㸸System menu screen is shown.
ᬆ Profile button 㸸Profile screen is shown.
ᬇ Buttons and functions
Contents
Sample㸸 ‫ۂ‬ Select for patient or calibration.
Select profile number and input profile name.
(Max. 8 characters)
Profile㸸 ‫ ۂ‬
¾ For the patient 㸹No. 1㹼20
¾ For the calibration : No.1㹼8
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Contents
Display of Item names which registerd in Item screen.
A ¾ Select registration Item.
¾ The back color chages to light after registration.
մ Delete button : Delete the profile registration.

Save button : Save the profile registration.
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4.9.5 Cell Blank screen
¾ All reaction cell Abs. of warer blank are displayed for each wavelength.
¾ The Abs. value is updated by each measurement.
¾ Confirm the cell condition.

ղЎ

ձЍ

ճ

A

Cell Blank screen
ᬅ System button 㸸Display of menu button in Systemscreen.

ᬆ Cell Blank button 㸸Display of Cell Checkscreen.
ᬇ Screen and functions
Contents
Cell Display the reaction cell position number.
340nm 㹼 800nm Display of each wavelength.
Display of cell balnk value for each reaction cell and
A
wavelength.
¾ There are three level for check level (Level 1. Level 2 and Level 3). If the value is
out of check level, back color change. Change the reaction cuvette if necessary.
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Contents
Cell blank is abnormal.(Abs. is too light)
Level 1 ¾ If the value below than level 1, back color is chaged to orange.
¾ Please perform the auto-gain.
The time for exchange is coming soon.
¾ If the value above than level 2, back color is changed to
Level 2
yellow.
¾ Please prepare the reaction cell exchange.
Cell blank is abnormal. (Dirty)
¾ If cell blank value above than level 3, back color is changed to
Level 3
red.
¾ Please change the reaction cells to new one.
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4.9.6 System Parameter screen
¾ Setting of measurement sequence, reagent tray and reagent remain.

¾ Parameters are set by the user requirement.

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ճ

մЎ

նЎ
յЎ

Parameter screen

ղ Parameter button 㸸Display of Parameter screen.
Contents Default
Calibration Select the sequence of calibration measurement.
Item
run sequence ¾ Select by Sample or by Item
Select the reagent tray.
Reagent Tray 36 bottles
¾ Select 24 Bottles or 36 Bottles.
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Contents Default
Selection for using sample position or sample
barcode. Display of order screen and result screen
Sample Mode Position
change by selected mode.
¾ Select Position or by Barcode.
System date setting.
Date
¾ Selection from calendar
Language selection.
Language Japanese
¾ Select English or Japanese
Selection for measurement timing of control
sample after calibration.
Control method (None) Discontinue Last
(Last) Continue after calibration.
¾ Select None or Last
Reagent remain selection
(In case of ͆Count͇)
The residual test count is shown which
calculated by Item parameter value
Checking Level
automatically. Count down one by one aspiration.
Reagent Remain sensor
(In case of ͆Level sensor͇)
The residual test count is shown which calculated
by probe movement automatically.
¾ Select count or level sensor.
Sample probe wash pattern setting
Sample Probe
¾ Select Between Items, between specimen and Specimen
Wash
Between samples.
Selection for display of reaction info. in main
Run Monitor screen. Sample No.
¾ Select by Sample No., Barcode and Patient ID.
Selection of print method for single report.
Single Report Manual
¾ Select by auto-print or manual print.
Selection for start the measurement during the
analyzer [WARM-UP] condition.
Warm up Disable
Measurment enable
Measurment disable
Selection for display of default specimen in order
screen.
Default
¾ Select by Serum, Urine, Plasma, CSF, Dialysis, Serum
Specimen
Other, HbA1c(Whole blood, Primary tube,
Hemolyzed)
Setting for default display of aspiration time in
Default
order screen. 1
Aspiration times
¾ Select from 1㹼10
Date change
Select date changing time. 0
timing (time)
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Contents Default
Display of reaction cell position number for next measurement
Initialize cell No. start.
(Start cell No.) ¾ Input reaction cell position number.
¾ Start reaction cell position can be set after ready.
Setting of warning level for reagent remaining.
Alarm:
¾ Input alarm level of test count. Default 5
Reagent remain
¾ Alarm will show when exceeds the level.
Setting of stop level for reagent remaining.
¾ Input stop level of test count or %.
(In case of the setting is “Count”
Stop: ¾ Stop the sampling automatically and display
Default 0
Reagent remain alarm
(In case of the setting is “Level)
¾ Display alarm, and continue the sampleing unitl
“S” flag occurrence.
Setting of acceptable calibration variation between
Allowable
the former results. (Standard Abs.̽Blank Abs.) Default 5
Calibration (%)
¾ Display error when exceeds the setting.
Select whether to execute automatic rerun
Auto Rerun OFF
¾ Select ON or OFF
Selection for no order entry of the test item is
acceptable when a test result of control sample is
Control Lockout OFF
a error B – F of Westgard check.
¾ Select ON or OFF
Select ON when using the QC tray.
QC Tray OFF
¾ Display QC sample tray (Pink).
Select ON when perform the sample detection.
Set in following condition.
¾ The screen changes depending on the LIS
Confirm sample ON
setting and sample probe wash setting.
¾ Please refer to Chapter 4, 4.9.7 Sample
confirmation screen.
ISE Setting of ISE Item measurement. OFF
Sample Barcode Setting of sample barcode. OFF
Reagent Barcode Setting of reagent barcode. OFF
Clot Sensor Setting of clot seneor. ON
Display Error Selection for display of data error.
******
Result ¾ Select value or asterisk (*).
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V1.00
մ Display of LIS communicartion

Refer to bi-directional communication specification.
Select the LIS communication.

¾ Select ON or OFF.(Default OFF)
Host
LAN settings
¾ Setting for LANcommunication condition.
HOST IPv4 Address㸸Setting of Host IP
address (IPv4).
Test orders
Test results
Patien information
Test reults inquiry
Test orders inquiry
LAN Settings screen Analysis name㸸

Host name㸸Laboratory Information System
Item master㸸Dysplay Item master screen.
OK : Save the LANsetting

Cancel : Cancel the setting and close the LAN
setting
Item Master screen
յ Save button㸸Register the displayed screen.
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4.9.7 Samlpe confirmation screen
¾ Popup screen displays after clicking Start button. Start the mensurement after
sample existing.
¾ Display when sample confirmation is On in system screen.the
¾ The screen changes depending on the LIS setting and sample probe wash
setting.

Ќ Ќ Ќ Ќ QC stert button
Ќ
ճ մ յ շ Ў
ն

ձЌ
ոЍ

Cup Result screen

ձ Start button
QC start button : Sample confirmation popup screen is shown.
ղ Sample confirmation screen : Confirm setting and start the measurement.

Contents
¾ In case of sample is set, sample position number
ղ Pos on the sample tray displays.
¾ If the sample is ordered, left column turns to blue.
In case of sample barcode setting, display of readed
chalacter.
մ Barcode
¾ Manual input is possible when barcode reading is
failed or error occured.
Select when the sample cup is used on the primary
յ Cup on Tube ‫ڧ‬
tube.
In case of the sample probe washing is selected ͆Between Samples”.
When perform the sample probe wash, select the wash
Wash Probe
ն timing before, after, before and after.
Wash Menu Select the detergent from W1-3.
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Contents
In case of the LIS communication setting is ON.
Request the sample barcode information.
¾ If the barcode reading is failed or error occurred,
շ Request
correct manually first. Then click Request button
for corrected information.
ո OK button : Start the measurement.
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4.9.8 Wash Settings screen㸦Carry over avoidance㸧
¾ Setting screen of wash configuration screen dispalys.

¾ Setting for Sampl probe (between Item and specimen), reagent probe and reaction
cell.

ղЎ

ձЍ

Ќն

ճ մ յ

Wash Settings screen
ᬅ System button 㸸Display of System menu screen.

ᬆ Wash Configuration button 㸸Display of Wash Configuration screen.
ᬇ Reagent Probe Wash screen
Contents
Select of carryover effecting test Item.

Item1
¾ Blank in Item selction means all the Items.
Select of carryover sensitive test Item.
Item2
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V1.00
Contents
Select of cleaning solution (Wash1-3) or water to avoid
Detergent
carryover.
Count Select washing time (1-10).
Delete a line Setting of the selected line is deleted.

Delete All All the settings are deleted.
¾ When select the [Water], detergent bottle setting is unnecessary.
մ Cell Wash screen

Contents
Select of carryover effecting test Item.

Item1
Select of cleaning solution (Wash1-3) or water to avoid
Detergent
carryover.
յ Sample Probe Wash screen

¾ The screen is changed depending on the sample probe wash setting.
¾ When the sample probe washing is set by sample, this setting is unnecessary.
Set in Sample confirmation screen.
Contents
Select of carryover effecting test Item or specimen.
Item1
Select of carryover sensitive test Item.or specimen.
Item2
Select of cleaning solution (Wash 1-3) or water to avoid
Detergent
carryover.
Count Select washing time (1-10).

ն Save button㸹Register the displayed screen.
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4.9.9 Reagent Barcode screen
Reagent barcode is set in this screen.

¾ ReagentBarcode is displayed by the user level.
¾ Input the reagent barcode format and maker code.
¾ Please refer to reagent barcode specification.

ղЎ

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ճ

Reagent Barcode screen

ᬆ Reagent Barcode button 㸸Display of Reagent Barcode screen.
ᬇ Display of reagent barcode setting screen.
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4.9.10 Manual Operation screen
Unit movement operates manually. Confirm the analyzer condition.

ղЎ

ձЍ

յ

մ
ճ

ն

Manual Operation screen

ձ System button 㸸Display of System menu screen.
ղ Manual Function button 㸸Display of Manual Function screen.
ճ Unit 㸸Display of unit name for manual function.
Unit
Unit name Movements
(abbreviations)
STF Sampler Rotation of sampler
Rotation of sample probe
STM Sample probe
Up/Down movement of sample probe
Aspiration/Dispensation movement of
SP Sample pump
samplepump
4-120

Unit
Unit name Movements
(abbreviations)
RGT Reagent tray Rotation of reagent tray
Rotation of reagent probe
RTM Reagent probe
Up/Down movement of reagent probe
RP Reagent pump
reagent pump
RCT Reaction tray Rotation of reaction tray
MU Mixing unit Up/Down movement of mixing unit
MP Mixing pump Movement of mixing pump
Cuvette washing Up/Down movement of reaction cell
CWS
station washing station
CWP Cuvette washing pump
reaction cell washing pump
PWP Probe washing pump
probe washing pump
DP Drainage pump Movement of drainage pump
Contents
Alarm Display of error state.
Level Display of liquid level statre for sample and reagent probes.
ISE ISE unitmovement and display of ISE unitstate.
մ Displays of manual function.

¾ Display the function by each unit movement.
Move the unit by clicking RUN or double click.
Move the unit by clicking CW, CCW, Up and Down button or double clicking..
¾ Back color turns to blue after selecting the function.
յ Each sensor state shows ON or OFF.
ն Common button for each unit screen.
Button Contents
Select when operating with “NO Safety”.
Cancel Safety
¾ No work for ISE function.
RUN Perform selected function.
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1. STF

ղ

ճ
ձ

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STF screen
ձ Functions
Movements
1 INIT To move to the home position.
2 OFFSET
ADJUST To input the angle to move by value, and to select the

3
direction of CW/CCW rotation.
4 CW 1PITCH (OUT) To move the outside cups clockwise by one pitch.

To move the outside cups counter-clockwise by one
5 CCW 1PITCH (OUT)
pitch.
6 CW 1PITCH (IN) To move the inside cups clockwise by one pitch.
To move the inside cups counter-clockwise by one
7 CCW 1PITCH (IN)
pitch.
PULL POSITION To move the aspiration position of selected cup.
8
¾ Input the cup position number.
SENSOR POSITION (IN) To move the cup sensor position of selected cup.
9
BARCODE POSITION To move the barcode position of selected cup position.
10
ղ Each sensor condition shows ON or OFF.
ճ Clicking Read button, encoder value is shown.
(Theoretical,Actual value,Allowable error㸧
մ Perform the function by clicking button.
Movements
Cancel Safety Select when operating with “NO Safety”.

4-122

2. STM

ղ

ճ
ձ

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STM screen
ձ Functions
Movements
1 ROTATE INIT To move to the home position.
2 OFFSET
ROTATE ADJUST To input the angle to move by value, and to select the
3
4 ROTATE REACTION CELL To move the reaction cell position.

5 ROTATE DILUTION CELL To move the dilution cell position.
6 ROTATE WASH To move the washing trough.
7 ROTATE SAMPLE (OUT) To move the aspiration position of outside sample cup.
8 ROTATE SAMPLE (IN) To move the aspiration position of inside sample cup.
9 ROTATE SAMPLE (ISE) To move the ISEsample pot.
10 UP/DOWN INIT To move the home position.
UP/DOWN ADJUST To input the distance by value ans select the direction
11
of UP/DOWN.
12 UP To move the up position.

13 DOWN Wash1 To move the down position to the trouph.
To move the down position to the washing position for
14 DOWN Wash2
primary tube.
To move the down position to the dispensation
15 DOWN Wash3
position of washing water.
To move the down position to the sample dispensation
16 DOWN Reaction cell
position at reaction cell.
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V1.00
Movements
To move the down position to the dilution sample
17 DOWN Dilution cell
aspiration position at reaction cell.
18 DOWN CUP㸦Level) To move the down position of cup by level sensor.
To move the down position of primary tube by level
19 DOWN Primary tube㸦Level)
sensor.
DOWN Trace samples To move the down position of micro cup by level
20
(Level) sensor.
21 DOWN ISE To move the down position of ISE sample pot.
ճ Clicking read button, encoder value is shown.
(Theoretical,Actual value,Allowable error㸧
Movements

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3. SP

ղ

ձ

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SP screen

ձ Functions
Movements
The washing side of pump; To move to the home
1 WASH INIT
position
The washing side of pump; Aspiration movement
2 WASH PULL (1000uL)
(1000uL).
The washing side of pump; Dispensation movement
3 WASH PUSH (1000uL)
(1000uL).
4 SAMPLE INIT The sample side of pump; To move to the home position
5 SAMPLE PULL (25uL) The sample side of pump; Aspiration movement (25uL)
The sample side of pump; Dispensation movement
6 SAMPLE PUSH (25uL)
(25uL)
SAMPLE PULL The sample side of pump; Aspiration movement
7
¾ Input aspiration volume.
SAMPLE PUSH The sample side of pump; Dispensation movement
8
¾ Input dispensation volume.
9 SV1 ON Electromagnetic valve EV-1 ON
10 SV1 OFF Electromagnetic valve EV-1 OFF
ճ Perform the function by clicking button.
Movements
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4. RGT

ղ

ճ
ձ

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RGT screen
ձ Functions
Movements
2 OFFSET
3 ADJUST To input the angle to move by value, and to select the
4 CW 1PITCH To move the clockwise by one bottle.

5 CCW 1PITCH To move the counter clockwise by one bottle
POSITION Selected bottle to move the aspiration position.
¾ Input bottle position number.
6
¾ In case of 36 Item tray, move to No.1㹼36 for R1
and No.37㹼72 for R2.
(Theoretical,Actual value,Allowable error,Position㸧
Movements
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5. RTM

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ճ

ձ

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RTM screen
ձ Functions
Movements
1 ROTATE INIT To move to the home position.( on the reaction cell)
2 ROTATE OFFSET
ROTATE ADJUST To input the angle to move by value, and to select the
3
R1 ROTATE REACTION
4 To move R1 probe to the reaction cell.
CELL
R1 ROTATE WASHING
5 To move R1 probe to the washing trough.
WASH
R1 ROTATE BOTTOLE
6 To move R1 probe to the aspiration position.
(IN)
R2 ROTATE REACTION
7 To move R2 probe to the reaction cell.
CELL
R2 ROTATE WASHING
8 To movee R2 probe to the washing trough.
WASH
R2 ROTATE BOTTOLE
9 To move R2probe to the aspiration position.
(OUT)
10 UP/DOWN INIT To move to the home position.
UP/DOWN ADJUST To input the angle to move by value, and to select the
11
Up/DOWN direction..
12 UP To move to the home position.

To move the down position R1 probe to washing
13 R1 DOWN WASH
trough.
R1 DOWN REACTION To move the down position R1 probe to the reaction
14
CELL cell position.
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V1.00
Movements
R1 DOWN To move the down position of R1 probe by level
15
BOTTLE(LEVEL) sensor.
To move the down position R2 probe to the washing
16 R2 DOWN WASH
trough.
R2 DOWN REACTION To move the down position R2 probe to the reaction
17
CELL cell position.
R2 DOWN To move the down position of R2 probe by level
18
BOTTLE(LEVEL) sensor.
㸦Theoretical,Actual value,Allowable error㸧
Movements

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6. RP

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ձ

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RP screen
ձ Functions
Movements
The washing side of pump; To move to the home
1 WASH INIT
position
The washing side of pump; Aspiration movement
2 WASH PULL (1000uL)
(1000uL).
The washing side of pump; Dispensation movement
3 WASH PUSH (1000uL)
(1000uL).
4 REAGENT INIT The reagent side of pump; To move to the home position
The reagent side of pump; Aspiration movement
5 REAGENT PULL (300uL)
(300uL).
The reagent side of pump; Dispensation movement
6 REAGENT PUSH (300uL)
(300uL).
REAGENT PULL The reagent side of pump; Aspiration movement
7
¾ Input aspiration volume.
REAGENT PUSH The reagent side of pump; Dispensation movement
8
¾ Input dispensation volume.
Movements
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7. RCT

ղ

ճ

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RCT screen
ձ Functions
Movements
2 OFFSET
N Pitch
3 To move by inputted pitch.
ADJUST To input the angle to move by value, and to select the

4
5 CW 1/2 PITCH To move clockwise by 1/2 pitch.

6 CCW 1/2 PITCH To move counter-clockwise by 1/2 pitch.
7 CW 1 PITCH To move clockwise by one pitch.
8 CCW 1 PITCH To move counter-clockwise by one pitch.
9 STAGE-A To move counter-clockwise by 13 pitches.
10 STAGE-B To move counter-clockwise by 21 pitches
11 STAGE-C To move counter-clockwise by 27 pitches.
POSITION
12 Input position number. Move to position unmber.
ղEach sensor condition shows ON or OFF.

㸦Theoretical,Actual value,Allowable error㸧
Movements
4-130

8. MU

ղ

ձ

ճЍ
MU screen

ձ Functions
Movements
ADJUST To input the distance to move by value,and select the
2
direction of Up or Down.
3 UP Up by setting pulse from the reaction cell.
4 DOWN Down by setting pulse from the reaction cell.
Movements

4-131

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9. MP

ղ

ձ

ճЍ
MP screen

ձ Functions
Movements
1 MP1INIT MP1㸸To move to the home position
2 MP1 CW To move to one cycle turn (Stops after one cycle turn).
3 MP1 Stop Stop the turn.
4 MP2 INIT MP2㸸To move to the home position
5 MP2 CW To move to one cycle turn (Stops after one cycle turn).
6 MP2 Stop Stop the turn.
Movements

4-132

10. CWS

ղ

ձ

ճЍ
CWS screen

ձ Functions
Movements
1 INIT To move to the home position
ADJUST To input the distance to move by value and select the
2
direction of Up or Down..
DOWN BOTTOM
3 To move the CWS to bottom position
POSITION
UP DISCHARGE
4 To move the CWS to dispensation position
POSITION
5 UP HOME POSITION To move to the home position.(up)
Movements

4-133

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11. CWP

ղ

ձ

ճЍ
CWP screen

ձ Function
Movement
1 One Cycle Aspiration and dispensation
Movements

4-134

12. PWP

ղ

ձ

ճЍ
PWP screen
ᬅ Functions
Movements
2 PULL (1000 uL) Aspiration movement (1000 uL)
3 PUSH (1000 uL) Dispensation movement(1000 uL)
Movements

4-135

V1.00
13. DP

ղ

ձ

ճЍ

DP screen
ᬅ Functions
Movements
1 DP1 ON DP1 movement ON
2 DP1 OFF DP1 movement OFF
3 DP2 ON DP2 movement ON
4 DP2 OFF DP2 movement OFF
Movements

4-136

14. Alarm
Alarm screen
ᬅ Display of the error condition. (exp. Tank error)

¾ ON means error occurred.
4-137

V1.00
15. Level
Level screen
ᬅ Display of the liqud level conditions for sample probe, reagent1 and reagent 2
probes.
Contents
Sample
1 Start Start data reading.
2 Stop Stop data reading.
3 Sampling Rate(ȣs) Select interval of liquid level information.
4 Set count Select repitation count (҄ in case 0).
5 Try count Display of action count.
Sample, Reagent 1 and Reagent 2.
1 (Left side) Display of graph.
2 Max Display of maximum value.
3 Min Display of minimum value.
4 Mean Display of average.
5 Range Display of range.

4-138

16. ISE
When select CRS Start,

Popup screen appears.
ճЍ
ISE screen
ᬅ Functions
Movement and display contents
1 Purge Cal-1 is sent to the sample pot and electrodeline.
2 Maint The liquid is discharged from the electrode line.
Wash to clean up the ISE unit.
3 ISE Wash ¾ Set a sample cup with ISE wash solution brfore
start.
4 Start Calibration Start the serum calibration measurement.
Start the CAL1 measurement by filled liquid in
5 CAL1 start
sample pot.
6 Sampling start Start the patient sample measurement.
7 Flow sensor reset Setting of air level sensor.
8 Calibration set Send the calibration result to the analyzer.
9 Aquire Flow sensor Data Reading of air flow sensor.
10 Debug mode Debug mode start and cancel.
11 ROM version Display of the ROM version.
12 Start Urine Calibration Start the urine calibration measurement.
13 Set Urine Calibration Send the urine calibrationresult to the analyzer.
14 Result Reading of latest result.
15 Calibration2 set
Start CRS measurement for ISEcorrelation㸧.
16 CRS start
¾ Input the boxes in pop-upscreen.

ճ Perform the function by Clicking buttons.
4-139

V1.00
Movement
RUN Perform selected function
4-140

4.9.11 Temperature screen
RCT and WSH temperature screen are shown.

¾ When intallation set up or changes the PC, input the temperature values to sensor
agjust by attached parameter sheet.

ղЎ

ձЍ

Ќ

յ
ճ

մ

Temperature screen
ᬅ System button 㸸Display of System menuscreen

ᬆ Temperature button 㸸Display of Temperature screen.
ճ Display of RCT (Reaction tray) temperature graph,
¾ Temperature screen is shown by user level.

Contents
Temp.
Sensor Adjust Υ Input the value in attached parameter sheet.
Target 37.00Υ Display of target value.
4-141

V1.00
¾ PID Factor is shown by user level.

Contents
PID Factor
Display of the controls.
Kp 12,Ki 12ࠊKd 1000,Ti 5,Td 2
Υ 㸣 Display of the RCT temperature and humidity.
մ Display of WSH (Washing water of pre-heater) temperature graph..

¾ Temperature screen is shown by user level.
Contents
Temp.
Sensor Adjust Υ Input the value in attached parameter sheet.
Target 38.00Υ Display of target value.
Υ 㸣 Display of the WSH temperature and humidity
ᬉ Save button 㸸Register the screen information.

4-142

4.9.12 Initialization screen
Input of offset parameter screen is shown.

¾ Initialyze screen is shown by the user level.

ղЎ

ձЍ

ճ

Initializetion screen

ᬆ Initializetion button 㸸Display of Initializetion screen.
ᬇ Display of offset values for each unit.
4-143

V1.00
4.9.13 Authority Settings screen
Setting of operation level for each user.

¾ The screen is shown after Login by sevice engineer level.

ղЎ

ձЍ

ճ

Authority Settings screen

ᬆ Authority Settings button 㸸Display of Authority settings screen
ᬇ Set the operation level for each user.
4-144

4.9.14 Version screen
¾ Version information of system program is shown.

ղЎ
ձЍ

ճ

Version Information screen

ᬅ System butto 㸸Display of System menu screen.
ᬆ Version button 㸸Display of Version Information screen.

ᬇ Version Information
Contents
User Interface Display of system program version number on the PC.
Display of control program version number on the
Sequence Control
analyzer.
Serial Number Display of analyzer serial number.
FPGA Version Display of FPGA version number.
Exit Close the Version screen.

4-145

V1.00
4.9.15 Log in screen
¾ The use level changing screen is shown.

ձЍ ղЎ

ճ

Log in screen

ᬆ Log off button 㸸Log in screen is popup.
Popup screen
ճ Log off screen.
Input and display contents
User Name Inputthe user level name.
Password Input the password.
Log in Log in by inputted level.
Close the Log off screen.
¾ System power turns OFF
Cancel
¾ Click system Icon when open the operation screen
again.

4-146

4.10 Exit screen
Shut down of system program and automatic maintenance setting screen is shown.
4.10.1 Exit button

ղ

ձЍ
Main screen ̿ Exit screen

ᬅ Exit button 㸸Display of Exit screen.

ղ Buttons and functions
Contents
Display of the setting screen for automatic start up and
Setup schedule start
maintenance procedurte.
End Turn OFF the system switch and exit the system program.
Cancel Close the exit screen.

4-147

V1.00
4.10.2 Setup schedule start screen
¾ Auto-start, shut down time and automatic mentenance setting screen displays.

ղ

ձЍ

ճ

Setup schedule start screen

ձ Exit button 㸸Display of Exit screen (End of Application).

ᬆ Exit screen 㸸Select the Setup schedule start.
ᬇ Setup schedule buttons and functions.
Contents
Wait Mode Move to auto-start waiting mode.
Start the End process Start the maintenance at end of the day.
4-148

Contents
Schedule Set the auto-start and maintenance procedure after start
up.
Sunday㹼Saturday ¾ Set the maintenance for each week day.
ON/OFF Select on, if the analyzer is st auto-start and maintenance.
Start time Select the maintenance start time.
End time Display of the maintenance end time automatically.
Select the function of automatic maintenance.
Function▼
¾ Select the function from the list.
¾ Automatic power on is done if the functionis not
selected.
End process ¾ Set the maintenance of end of the day and setting after
shutdown.
□After Power OFF In case of power off after maintenance, check the box ࣞ.
□Wait Mode In case of move to auto-start mode, chek the box ࣞ.
Function▼ Display of maintenance list.
Select the automatic maintenance function.
Clear Delete the displayed information.
Seve Register the displayed information.
Exit Close the setup schedule screen.
4-149

Chapter 5 Maintenance

Safety caution ................................................................................................................. 2

Preparation of maintenance list and update the date. ................................................. 2
Maintenance list ............................................................................................................. 3
5.3.1 Periodic check and Periodic exchange ...................................................................... 3
Maintenance procedure.................................................................................................. 4
5.4.1 Sample probe check and cleaning ............................................................................ 4
5.4.2 Reagent probe check and cleaning ........................................................................... 5
5.4.3 Leakage of pumps (SP, RP, PWP) ............................................................................. 6
5.4.4 Confirmation of the water supply tank volume........................................................ 6
5.4.5 Confirmation of the water purification system and purity of pure water machine .. 6
5.4.6 Confirmation of the volume Alkaline and Acid detergent tanks .............................. 6
5.4.7 Drainage reservoir ................................................................................................... 7
5.4.8 Cleaning and confirmation of the strain on the cell cover ........................................ 8
5.4.9 Cleaning of cooling filter .......................................................................................... 8
5.4.10 Special wash............................................................................................................. 9
5.4.11 Cleaning of ISE sample pot .................................................................................... 10
5.4.12 ISE Wash (Cleaning of ISE sample line) ................................................................ 11
5.4.13 Reaction cell exchange ........................................................................................... 12
5.4.14 Exchange of lamp ................................................................................................... 13
5.4.15 Auto gain (Gain adjustment).................................................................................. 15
5.4.16 Exchange of sample probe ...................................................................................... 16
5.4.17 Exchange of reagent probe ..................................................................................... 16
5.4.18 Exchange of Water filter......................................................................................... 17
5.4.19 Exchange of Calibrator 1 (Cal-1) ............................................................................ 18
5.4.20 Exchange of electrode............................................................................................. 19
5.4.21 Exchange of roller pump tube ................................................................................ 20
5.4.22 Exchange of pinch valve (PV) tube ......................................................................... 21
5.4.23 Removal of bubbles at electrode ............................................................................. 23
5.4.24 Storage of electrodes .............................................................................................. 24
5-1

V1.00
Safety caution

¾ Please follow the warning and safety caution which informed in “Chapter
Preface” of operation manual.
When do maintenance operation, wear protective globes, mask and glasses

to avoid infection.

Preparation of maintenance list and update the date.
¾ Please prepare “Maintenance list” for analyzer maintenance and parts exchange.
Manage the list by updating the date.
Maintenance list screen
Order Buttons & screen Operation & Display

Prepare maintenance list.
1 ձ System Open System screen.
2 ղ Maint. list Open Maintenance list screen.
Select maintenance period.
3 ճ ▼ (Daily, Weekly, Monthly, 3 months,
half year, one year, two years)
4 մ Content Input operation.
5 յ Save Register the operation.
Update the operation date.
6 ն Check box Check the box □ after operation.
Update the operation date and next operation
7 յ Save
date.
շ Latest date Display updated date.
8
ո Expiration date Display expiration date.
5-2

Maintenance list
5.3.1 Periodic check and Periodic exchange
¾ Periodic check list (for customer)
Remarks
1 mth
3 mth
6 mth
if need
dairy
week
1 yr
㻌 Contents
1Cleaning of sample probe 䕿

2Cleaning of reagent probe 䕿
3Check of the SP water leak 䕿
4Check of the RP water leak 䕿
5Check of the PWP water leak 䕿
6Check of the water supply tank volume 䕿
Check of the volume and purity of pure
7 䕿
water machine
Check of the volume Alkaline detergent
8 䕿
tank
9 Check of the volume Acid detergent tank 䕿
10 Check of the drainage tank volume 䕿
Cleaning and check of the strain of the
11 䕿
cell cover
12 Cleaning of cooling filter. 䕿
13 Special washing 䕿
ISE unit
14 Cleaning of sample pot. 䕿㻌㻌㻌㻌㻌㻌
15 Cleaning of ISE sample line 䕿㻌㻌㻌㻌㻌㻌
¾ Periodic exchange list (for customer)
Remarks
1 mth
3 mth
6 mth
if need
dairy
week
1 yr
㻌 Contents
1 Exchange of reaction cells 㻌 ‫ۑ‬

2 Exchange of lamp 㻌 ‫ۑ‬
3 Exchange of sample probe ‫ۑ‬
4 Exchange of reagent probe ‫ۑ‬
5 Exchange of water filter 䕿
ISE unit
6 Exchange of Cal 1 pack 䕿㻌
7 Exchange of Na electrode 䕿
8 Exchange of K electrode 䕿
9 Exchange of Cl electrode 䕿
10 Exchange of Ref. electrode 䕿㻌
11 Exchange of roller pump tube. 䕿
12 Exchange of pinch valve tube. 䕿
5-3

V1.00
Maintenance procedure
5.4.1 Sample probe check and cleaning
¾ Confirmation of sample probe bending.

¾ Remove the dirt (protein) of probe tip.
Inspection period Everyday
Necessary parts Gloves, KIMWIPE, DI water, Nylon wire
1) Turn off the PC and analyzer

system power switch before
starting the maintenance
operation.
2) Remove the sample tray cover.
3) Remove a sample tray if it is
inserted.
4) Confirm the probe straight.
5) Pull up STM arm by hand and
move and rotate to above the
sampler.
6) Wipe out the dirt at the outside of
probe tip by KIMWIPE or other
material soaked in DI water.
¾ Thread the nylon wire from probe tip
and clean up the sample probe if
necessary.
Note
Be careful not to bend the probe
tip.
7) Return STM arm to washing

position by hand.
8) Reset sampler tray cover at the
proper position.
5-4

5.4.2 Reagent probe check and cleaning
¾ Confirmation of reagent probe bending.

¾ Remove the dirt (protein) of probe tip.
Necessary parts Gloves, KIMWIPE, DI water
1) Turn off PC and the analyzer system

power switch before starting the
maintenance operation.
2) Remove reagent tray cover.
3) Remove the reagent tray.
4) Move up RTM arm by hand and
rotate R1 to the reagent bottle
position.
5) Wipe out the dirt at the outside of
probe tip by KIMWIPE or other
material soaked in DI water.
6) Return RTM to the home position by
hand. Rotate R2 probe by hand and
clean up the R2.
Note
Be careful not to bend the probe
tip.
7) Return RTM to the home position by

hand. (R2 is front side)
8) Place back reagent tray and tray
cover.
5-5

V1.00
5.4.3 Leakage of pumps (SP, RP, PWP)
¾ Confirmation of water leakage.

Necessary parts None
5.4.4 Confirmation of the water supply tank volume
¾ Check the water tank volume.

Necessary parts None
5.4.5 Confirmation of the water purification system and purity of pure

water machine
¾ Check the water supply system.

Necessary parts Follow the purify system manual.
5.4.6 Confirmation of the volume Alkaline and Acid detergent tanks
¾ Check the Alkaline and Acid detergent volumes.

¾ Refill the detergent if required.
(Alkaline㸻Dilute to 2% for use ,Acid㸻Dilute to 1% for use.
In case of confirmation: No
In case of refill the detergent :
Necessary parts ࣭Gloves
࣭Washing Solution Alkaline (Fast Detergent 1):(Code SP2208)
࣭Washing Solution Acid (Fast Detergent 2 ):(Code SP2209)
5-6

5.4.7 Drainage reservoir
¾ Confirmation of drainage reservoir volume.

¾ Clean up the dirt of float sensor which can’t detect the liquid level correctly.
In case of confirmation: No
Necessary parts
In case of waste: Gloves, KIMWIPE

1) Loosing cap of the reservoir and pull
up the float switch unit.
2) Wipe out water around the filter and

other part by KIMWIPE for better
working condition.
3) Confirm if the float switch moves up

and down smoothly.

4) If you find dirt around the float
switch, wash out dart by tap water
with brush.
5) Return the float switch unit into the

drainage reservoir.
6) Tighten the cap.

5-7

V1.00
5.4.8 Cleaning and confirmation of the strain on the cell cover

¾ Clean up the cell cover if necessary.
Necessary parts Gloves, KIMWIPE, DI water

5.4.9 Cleaning of cooling filter

¾ Clean up the reagent tray cooling filter.
Inspection period If necessary
Necessary parts Gloves

5-8

5.4.10 Special wash

¾ The dirt of reaction cells, sample probe and reagent probes are influenced to the
measurement results. Clean up by using special wash program.
¾ Use 6% diluted solution of detergent.
Inspection period If necessary.
Gloves
Necessary parts Washing Solution Alkaline (Fast Detergent 1):(Code SP2208)
Washing Solution Acid (Fast Detergent 2 ):(Code SP2209)
Wash time About 30 minutes
¾ Special wash means?

All the reaction cells and probes are washed in the same procedure as
measurement by aspiration and dispensation of detergent instead of reagent
and sample.

¾ Kinds of using detergent
Select the detergent depending on the target.
࣭Alkaline detergent: For protein base stain
࣭Acid detergent: For metallic base stain

¾ Special wash button
There are three kinds of special wash buttons.
Special wash 1: Use reagent bottle wash 1 and sample tray position W1.

¾ Special wash procedure
1) Set detergent bottle on the reagent tray.
2) Set detergent cup at cup position(W1, W2, W3) on the sample tray.
¾ Please refer to Chapter 3 Routine operation procedure.
¾ Pour the detergent to R 1 bottle 20mL, R2 bottle 11mL and Sample cup
2mL.
3) Click Maint. button in main screen, and open maintenance screen.
4) Pointed and click the button in Special wash 1, Special wash 2 and
Special wash 3.
5) Start the washing.
6) Stop automatically after washing.

5-9

V1.00
5.4.11 Cleaning of ISE sample pot

¾ Clean up the sample pot to avoiding the clot for ISE sample line.
Necessary parts Gloves, Cotton swab (narrow type), DI water

1) Open the ISE door on the right
panel of the system at right
angles to the system for ISE
storage facing front.

2) Clicking Maint button in the
main screen.

3) Clicking ISE Mainte, and empty the
ISE line.
4) Moisten the cotton swab with DI
water.
5) Confirm no liquid in sample pot.
Clicking ISE Maint again if
liquid is found in sample pot.
6) Insert cotton swab to clean up

inside of the pot.
Note:
Be careful not remain the thread
which makes clot.
7) Close the ISE door.
8) Click ISE Purge button, and refill
the sample line.

5-10

5.4.12 ISE Wash (Cleaning of ISE sample line)

¾ Clean up the ISE sample line.
¾ After ISE wash, calibration is necessary before starting ISE test.

Gloves,
Necessary parts Cleaning Solution ( 25ml ) (Code 20-27-0479F)
ͤAs necessary use ISE Cleaner 1% (25ml) (Code 50-27-0781)
Wash time About 6 minutes
Note
It is recommended to do cleaning by ISE Cleaner 1% once a week when the
ISE test is measured above 60 test per week.
ISE Washing solution 1) Pour the 400uL washing solution

400uL in sample cup.
2) Set the detergent cup at the
ISE Wash position on a sample
tray.
3) Clicking Maint. button.
4) Clicking ISE Wash button.
5) Upon clicking, cleaning solution
is dispensed in ISE to clean up
the inside of ISE sample line.
6) Remove the sample cup after
cleaning

5-11

V1.00
5.4.13 Reaction cell exchange

¾ The dirty cells are influenced to the measurement results. Please exchange the
reaction cells when the cell condition of back color shows red in cell check screen.
¾ Change all the 60 cells at once.
Exchange interval If necessary
Gloves, Hexagonal wrench (2.5mm)
Necessary parts
Cuvette -8U (60 Pieces) (Code 23-07-0055)
1) Turn off PC and the analyzer system

power switch.
2) Pull up RTM arm and turn to tough.
3) Pull up cell cover and remove it.
4) Rotate reaction tray by hand so that a
reaction cell group comes to the front.
Note
20 reaction cells are held by the cell
holder. Cell position number is
printed on the cell holder in 5 intervals.
5) Loosen cell holder screws (3 screws)
by hexagonal wrench (2.5 mm) so that
you can remove cell holder.
6) Pull up cell holder and remove it.
7) Pull up the cell, to be replaced, by
fingers.
8) Insert a new reaction cell, confirming
the direction to insert.
Note
Do not touch the optical path face
of a reaction cell by fingers.
9) After the reaction cell insertion, fix a
cell holder by a hexagonal wrench.
10) When you have finished cell
replacement, confirm each cuvette
is set properly, by rotating the tray
carefully by hand.
11) Power ON PC and analyzer.
12) Initialize the analyzer.
13) Set the cell cover to the proper
position. Fit the cell cover cut part
to the pin.
5-12

5.4.14 Exchange of lamp
¾ The lamp deterioration is influenced to the measurement results. Please exchange

the lamp if the life time is over (about 1200 hours).
¾ After finishing the lamp exchange, adjust the gain and update the
remaining time. Refer to Chapter 5, 5.3.14 Auto-gain.
Gloves,
Necessary parts
Halogen lamp (Code 60-00-0001)
Caution
Caution High temperature
The temperature of the lamp rises during operation, and it might

cause burn on your fingers. Don’t touch directly.

1) Turn off the PC and the system
power switch and wait for ten
minutes to cool the lamp and lamp
house before starting the
maintenance operation.
2) Open top cover.

3) Slide and open the lamp house cover.
4) Remove the lamp connector by

pressing both side fixing pins.
5-13

V1.00
5) Turn the lamp holding plate to

counter clockwise, and remove it.
6) Pull up the lamp from lamp hol
ding ring by pressing both side
fixing pins on the white connecto
r.
7) Holding the wiring by fingers,
pull up the lamp.
Note
Don’t touch the lamp which rises
high temperature.
8) Set a new lamp, fitting the slit

of the lamp flange to the pin
on the lamp holding plate.
Note
Do not touch the glass surface
of the lamp.
9) Path the lamp to fixing ring by

pressing the pin.
10) Turn the lamp holding plate to
clockwise , and fix it.
11) Connect the connector.
12) Replace the lamp cover by sliding
down.
13) Select lamp Icon in main
screen.
14) Select change button, and update
remain time.
Pin
New lamp
5-14

5.4.15 Auto gain (Gain adjustment)
¾ When finishing the lamp exchange, perform to adjust the gain

(Adjustment of the intensity of light).
Inspection period After lamp exchange
Necessary parts Gloves, Hexagonal wrench (2.5mm)
Note
Please perform the gain adjustment with stable lamp.
1) Turn on the PC and system power switch and wait for 20 – 30 minutes.
2) Clicking Mainte. button, maintenance screen is shown.
3) Clicking Auto Gain button.
4) Pop-up screen is shown after analyzer movement.
5) Remove the reaction cell of No.50 position.

Refer to Chapter 5, 5.3.13 Reaction cell exchange.
Note
Do not touch the optical path face of a reaction cell by fingers.
6) Clicking OK button.
7) The gain for all the wavelengths is automatically executed.
8) The auto-gain information is shown on the screen.
9) When finishing the auto-gain, popup screen is shown.
10) Clicking OK button, saving the data.
5-15

V1.00
5.4.16 Exchange of sample probe

¾ Please exchange the sample probe to keeping the accuracy and precision when
required.
Gloves,
Necessary parts
Sample probe (Code 60-02-0020)

5.4.17 Exchange of reagent probe

¾ Please exchange the reagent probe to keeping the accuracy and precision when
required.
Necessary parts Reagent probe(Code 60-03-0034)

5-16

5.4.18 Exchange of Water filter
¾ Please exchange the water filter to avoiding the influence of measurement results.
Exchange interval Every 6 months.
Gloves, KIMWIPE,
Necessary parts
Water filter (Code SP2058)

1) Loosen the cap of the water
reservoir and pull up the filter and
the float switch unit.
2) Wipe out water around filter and

other parts by KIMWIPE for better
working condition.
3) The old filter is pulled down to

remove.
Float switch
Filter
4) Insert a new filter till the filter hits a

stopper.
5) Confirm if the float switch moves up

and down smoothly.
6) Return the filter and the float switch

unit into the water reservoir.
7) Tighten the cap.
5-17

V1.00
5.4.19 Exchange of Calibrator 1 (Cal-1)
¾ The ISE unit is filling the sample line and electrodes by Calibrator 1
automatically. Please change the Calibrator 1 to avoiding the dryness.
Exchange interval One month after open or when necessary
Gloves,
Necessary parts
Calibrator 1 F( 420ml ) (Code 20-27-0477F)

2) Clicking ISE Maint button, and
empty the ISE line.
3) Holding the used Cal-1 pack
upsideup, remove the cap.
Takeoff the cap from hook to
dispose.
4) Keeping the new Cal-1 pack
upside up, and unscrewthe cap.
5) Screw the cap into new Cal-1 pack,
holding it upside up to removing the
air.
6) Hang up the new Cal-1 pack.
7) Perform ISE Purge order in ISE
Maint. screen.
8) Repeat ordering ISE Purge till no
bubble comes out from the tube
and the liquid is sucked up.
9) Confirming that no error occurs.
Note
Please check totally when error
occurred.
5-18

5.4.20 Exchange of electrode
¾ The deterioration of electrode reduces the slope value. The slope error or drift
error occurs. Please change the electrode if the error can’t solved after ISE
maintenance.
Gloves,
Na Electrode F (Code 20-27-0474F)
Necessary parts K Electrode F (Code 20-27-0475F)
Cl Electrode F (Code 20-27-0476F)
Reference Electrodes F (Code 20-27-0473F)

1) Open the ISE door on the rightSanel of
the system at right angles to the
system for ISE storage facing front.
3) Clicking ISE Maint button, and empty
the ISE line.
4) Open the electrode cover, and press
holding plate.
5) While holding the plate down, pullout
electrode.
6) Draw the fixing plate from the old
electrode.
7) Insert the fixing plate to the new
electrodes.
8) Keep holding the plate down, and
insert the new electrode pushing back.
9) Perform ISE Purge order, and refill
the line.
10) Confirm there is no leakage from the
electrode.
Note
If leakage is found, repeat from
6 to 9 again.
11) Confirming no error occurred.
Note
occurred.
12) Close the electrode cover, and close ISE
door.
5-19

V1.00
5.4.21 Exchange of roller pump tube

¾ The deterioration of roller pump tube influences the liquid flow. Please change it
periodically.
¾ Please exchange the pump tubes both calibrator and waste simultaneously.
Exchange interval Every 3 months
Gloves, Screw driver
Necessary parts Roller Pump Tube B (2 pieces of tubes) (Code 20-30-0610)
Roller Pump Tube Grease (Code 20-30-0581)

1) Remove Cal-1 pack from the hook to
prevent leaking from the tube.
2) Loose the fixing screw, and remove
front panel by disconnecting the
connectors.
3) Clicking Maint button.
4) Clicking ISE Maintbutton, and empty
the ISE line.
5) Turn the lever presser 90 degrees to
outside, loosen the lever.
6) Remove the pump tube joint from the
hook.
7) Remove the pump tube and exchange to
new pump tube.
8) Paste the grease of roller pump tubeto
new one thinly.
9) Hang the pump tube joint on the center
of the roller.
10) By pressing the lever, turn the lever
presser 90 degrees to inside
11) Hang Cal-1 pack on the hook.
12) Perform ISE Purge order, and refill the
line.
13) Repeat ISE Purge order till no
bubble comes out from the tube and
the liquid is sucked up.
14) Confirming no error occurs.
Note
occurred.
15) Connect the connectors, and replace
the front panel.

5-20

5.4.22 Exchange of pinch valve (PV) tube
¾ The deterioration of pinch valve tube influences the liquid flow. Please change it
periodically.
¾ Please exchange the PV tubes both front and rear side simultaneously.
Exchange interval Every one year
Gloves, Screw driver
Necessary parts
Pinch Valve Tube F (Code 20-27-0487F)

1) Remove Cal-1 pack from the hook to

prevent leaking from the tube.
2) Loose the fixing screw, and remove
front panel by disconnecting the
connectors.
3) Clicking Maint button.
4) Clicking ISE Maint button, and empty
the ISE line.
5) Remove the fitting .
Pull under part of fitting in front.

6) By pressing the fixing projection, remove
the front PV tube.
Keep the tube connection.

7) Remove the PV tube inserted in the
groove of pinch valve.
8) Exchange to new PV tube.
9) Remove the rear PV tube.
Please use tweezers to removing easily.
10) Assemble the rear PV tube.
The rear tube has no connection.
Please use tweezers to set easily.

5-21

V1.00
11) Assemble the front PV tube

The front tube is connecting the tube.

12) Insert the fitting.
13) Hang Cal-1 pack on the hook.
14) Perform ISE Purge order and refill the
line.
15) Repeat ISE Purge order till no bubble
comes out from the tube and the liquid is
sucked up.
16) Confirming no error occurs.

Note
occurred.

17) Connect the connectors, and replace
the front panel.
5-22

5.4.23 Removal of bubbles at electrode
¾ The ISE unit can’t detect the ions if the electrode has a bubble inside.
¾ When exchange the electrode, removal of bubbles is essential.
The explanation is given for Ref electrode, but keep other electrodes likewise.
Inspection period When exchange the electrode, if necessary
Necessary parts Gloves, Syringe(with tip), DI water
Micropipette 1) Peel off the seal on the air hole of the

electrode, and leave it open.
Seal 2) Fill the syringe with DI water.
3) Insert the tip of the syringe from the
Passage joint end of the passage joint to the ion
passage.
4) Make a rush of DI water from the
syringe.
5) The bubble is removed, and DI water
spills over from the end of the passage
joint.
Note
Please use 10mL syringe.
Don’t rush strongly why the
electrode membrane will damage.
Don’t push till finish the liquid
inside the syringe. It makes
another bubble.
5) Pull out thesyringe.

6) Make sure that no bubble is in the ion
passage of the electrode.
If there is still any bubble, repeat the
procedure from 2).
7) Wipe off the spilt liquid all over the
electrode, if any.
5-23

V1.00
5.4.24 Storage of electrodes
¾ In case of turning off the power of ISE unit more than four days, keep the
electrodes as follows.
The explanation is given for Ref electrode, but keep other electrodes likewise.
Inspection period When storage the electrode

࣭Gloves, Syringe (with tip)
Necessary parts ࣭Calibrator A (20mL) + Calibrator B (20mL) set
(Code60-22-0263F)
1) Remove the electrode.

Refer to Chapter5,5.4.20Exchange of
Electrode
2) Fill the syringe with Calibrator A or B.
3) Fill the passage of the electrode with
Calibrator A or B, using syringe.
4) Fix the attached seals to the both ends
of the passage not to let the liquid leak
out.
Note
Wipe off around the exits before fixing
the seals. Also, wipe out the spilt
liquid.
5) Put the electrodes in each case to keep

at the room temperature.
5-24

V1.00 2016/03/01
Consumables List
Code No. Parts Name Qty. Memo

1 20-22-0391 Sample Cup 1000 pieces
2 60-00-0001 Halogen lamp 1
3 SP2058 Water filter 5 Pieces
4 23-07-0055 Cuvette -8U 60 Pieces
5 23-30-0676 Drying Nozzle Tip 2 Pieces
Washing Solution Alkaline 500ML X5
6 SP2208
(Fast Detergent 1) Pieces
Washing Solution Acid 500ML X5
7 SP2209
(Fast Detergent 2 ) Pieces
8 60-08-0083 Packing 4 Pieces
9 60-02-0020 Sample Probe 1
10 60-03-0034 Reagent Probe 1
11 20-22-0396 Reagent bottle 60ml (with Cap) 20 Pieces for 24 item tray
12 60-22-0265 Reagent Bottle - T2 40ml (with cap) 20 pieces for 24 item tray
13 60-22-0264 Reagent Bottle - T2 20ml (with cap) 20 pieces for 24 item tray
14 SP2225 Reagent bottle Cap 20 Pieces
15 20-30-0584 Reagent bottle 40ml ( with Cap) 20 Pieces for 36 item tray
18 20-22-0399 Reagent bottle Cap 20 Pieces

¾ ISE accessory
Code No. Parts Name Qty. Memo
1 20-27-0474F Na Electrode F 1
2 20-27-0475F K Electrode F 1
3 20-27-0476F Cl Electrode F 1
4 20-27-0473F Reference Electrodes F 1
5 20-27-0477F Calibrator 1 F ( 420ml ) 1
Calibrator A (20mL) + Calibrator
6 60-22-0263F 1+1
B (20mL) set
7 20-27-0479F Cleaning Solution ( 25ml ) 1
8 50-27-0781 ISE Cleaner (1%) 1
Roller Pump Tube B for New roller 2 pieces of
9 20-30-0610
pump tubes
2 pieces of
10 20-27-0487F Pinch Valve Tube F
tubes
7 pieces of
11 20-27-0488F Piping Tube Set F
tubes
12 20-27-0480 Urine Calibrator 1, 2 10 ampoules
13 20-27-0482 Urine Diluent ( 500ml ) 1
14 20-27-0483F Dialysis Liquid Calibrator D F 20 Pieces


Operator’s Manual, Ver1.00
Published: May 10, 2016
Printed in Japan

Biolis 30i

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Automated Clinical Analyzer

TOKYO BOEKI MEDISYS INC.

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We appreciate your adoption of our Automated Clinical Analyzer.

Manufactured by Tokyo Boeki Medisys Inc.

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࣭Modification for the analyzer

Addition of an attachment, supplied from the other maker than us.

࣭Self-repair or parts replacement

Self-adjustment of the points, assigned as qualified service engineer only.

© Copyright 2011 Tokyo Boeki Medisys Inc.

࠙Windowsࠚis a registered trademark of Microsoft USA.

This product meets the requirements of CSA.

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Software license agreement

The purpose of this Software license agreement is to establish mutual agreement

1 The right to use

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5 Guarantee and responsibility limit

6.2 The action violating the law and regulation.

6.6 The action of publish or transmitting false information or information

6.7 The action contrary to other public order and morals.

8 Cancellation of the agreement

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9 The action after the agreement has over

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Chapter1 [Specifications and structure of the System]

Chapter2 [Functions and principles]

Chapter3 [Explanation of each screen and operating condition]

Chapter4 [Explanation of each screen and operating condition]

Chapter6 [Check flag and alarm function]

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Introduction ---------------------------------------------------------------------- 0-2

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1. Expression of Warning and Notice

Note 㸸Pay attention, additional explanation.

Description of the mark

㸸This mark means electric shock if touched.

㸸This mark means high temperature. Keep out from burn.

㸸This mark means do not touch with wet hand.

㸸This mark means electric ground is necessary.

㸸This mark means to protect eye, wear protective goggle.

㸸This mark means do not touch with naked hand.

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Explanation of caution and warning seal

The following seal are stuck on the analyzer body as warning.

1) Warning label of top cover

Revolution, vertical movement hazard

2) Right side cover㸹ISE unit, Water supply/drain panel

Revolution, vertical movement hazard

3) Upper panel warning label

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High temperature hazard

Revolution, vertical movement hazard

Revolution, vertical movement hazard

Revolution, vertical movement hazard

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2. Safety Caution ࣭Caution in Operation

1) Moving parts while operation

2) Light from light source㸭Bar code reader LED class 1

4) Waste liquid treatment